FDA Inspection 1153105 — Grace Analytical Lab Inc
The FDA completed an inspection of Grace Analytical Lab Inc on Sep 29, 2021 in Berkeley, IL. 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). 9 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 29, 2021
- Fiscal Year
- 2021
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Berkeley, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1168 | 21 CFR 211.34 | Consultant Records |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2399 | 21 CFR 211.194(a)(2) | Laboratory Test Method Verification |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |