FDA inspection

Pramand LLC: FDA inspection ending Nov 2, 2022

FDA inspection 1190493 · No Action Indicated (NAI) · Bedford, Massachusetts

Key facts

Inspection ID	1190493
Firm	Pramand LLC
FEI number	3016980830
Address	201 Burlington Rd
City	Bedford
State	Massachusetts
ZIP	01730
Fiscal year	2023
Inspection end date	Nov 2, 2022
Classification	No Action Indicated (NAI)
Project area	Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Postmarket Assurance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Postmarket Assurance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Postmarket Assurance: Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Devices\|Postmarket Assurance: Medical Devices\|Product Evaluation: Medical Devices
Product type	Devices

At a glance

None Citations
None Posted citations
No Warning letter followed
Yes Form FDA 483 issued
No Establishment inspection report (EIR) exists
1–9 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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