FDA Inspection 695821 — Verichem Laboratories, Inc.
The FDA completed an inspection of Verichem Laboratories, Inc. on October 29, 2010 in Providence, RI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 29, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Providence, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3139 | 21 CFR 820.140 | Lack of or inadequate procedures for handling |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |