FDA Inspection 1166244 — Forcemech International LLC
The FDA completed an inspection of Forcemech International LLC on April 4, 2022 in Pearland, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 4, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pearland, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |