FDA Inspection 1121044 — Forcemech International LLC
The FDA completed an inspection of Forcemech International LLC on Mar 17, 2020 in Pearland, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 17, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pearland, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |