FDA Inspection 903994 — Verichem Laboratories, Inc.
The FDA completed an inspection of Verichem Laboratories, Inc. on November 14, 2014 in Providence, RI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 14, 2014
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Providence, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 3698 | 21 CFR 820.150(b) | Procedures - receipt and dispatch |