FDA Inspection 977465 — Thatcher Company, Inc.
The FDA completed an inspection of Thatcher Company, Inc. on December 10, 2015 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 10, 2015
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |