FDA Inspection 1067393 — Thatcher Company, Inc.
The FDA completed an inspection of Thatcher Company, Inc. on Sep 18, 2018 in Salt Lake City, UT. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 18, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1222 | 21 CFR 211.67(b)(4) | Cleaning SOPs/equipment identification |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |