FDA Inspection 997633 — Advanced Testing Laboratory, Inc.
The FDA completed an inspection of Advanced Testing Laboratory, Inc. on December 21, 2016 in Milford, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 21, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Milford, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 4403 | 21 CFR 211.194(b) | Test method modification records do not include |