Orca1

FDA inspection

Instylla, Inc.: FDA inspection ending Jun 6, 2025

FDA inspection 1272430 · No Action Indicated (NAI) · Bedford, Massachusetts

Key facts

Inspection ID 1272430
Firm Instylla, Inc.
FEI number 3017208642
Address North Building, 201 Burlington Rd
City Bedford
State Massachusetts
ZIP 01730
Fiscal year 2025
Inspection end date Jun 6, 2025
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: 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.

Other inspections at this establishment

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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