FDA Inspection 857338 — Pharma Tech Solutions, Inc
The FDA completed an inspection of Pharma Tech Solutions, Inc on December 9, 2013 in Westlake Village, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 9, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westlake Village, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |