FDA Inspection
Flexion Therapeutics, Inc.Flexion Therapeutics, Inc. – FDA Inspection, Jun 13, 2017
Record Details
This FDA Inspection record concerns Flexion Therapeutics, Inc., with an inspection on June 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d57d79cc-b8b0-40ac-ba68-de65c43075e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013962
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
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