FDA Inspection
Flex-Cell Precision, IncFlex-Cell Precision, Inc – FDA Inspection, Mar 27, 2019
Record Details
This FDA Inspection record concerns Flex-Cell Precision, Inc, with an inspection on March 27, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff270666-13f9-4a4b-9f3e-6f877fc8d7c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089368
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
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Other FDA inspections of Flex-Cell Precision, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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