FDA Inspection 788542 — Health-Chem Acquisitions, LLC
The FDA completed an inspection of Health-Chem Acquisitions, LLC on Sep 27, 2012 in Pompano Beach, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 12 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Sep 27, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14711 | 21 CFR 820.160(a) | Lack of or inadequate procedures for distribution |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 537 | 21 CFR 820.70(a) | Production processes |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |