FDA inspection

North American Diagnostics: FDA inspection ending Jun 23, 2022

FDA inspection 1172559 · Holly Hill, FL

Key facts

Inspection ID	1172559
Firm	North American Diagnostics
FEI number	3021477751
Address	618 Ridgewood Ave Ste 100
City	Holly Hill
State	FL
ZIP	32117-3604
Fiscal year	2022
Inspection end date	Jun 23, 2022
Project area	Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Med Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices\|Compliance: Medical Devices\|Postmarket Assurance: Med Devices\|Postmarket Assurance: Medical Devices
Product type	Devices
Warning letter	643203

At a glance

None Citations
1–9 Posted citations
Yes 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.

About FDA inspections

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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