FDA Inspection
Forcemech International LLCForcemech International LLC – FDA Inspection, Mar 17, 2020
Record Details
This FDA Inspection record concerns Forcemech International LLC, with an inspection on March 17, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Forcemech International LLC
- Inspection Date
- March 17, 2020
- Product Type
- Devices
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ID · cd108f27-73e5-4cee-97aa-46debe679dc8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1121044
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.160(b)Distribution records
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.200(d)Service reports
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Other FDA inspections of Forcemech International LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 6, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 4, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 16, 2021 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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