FDA Inspection 845891 — Clavel Corporation
The FDA completed an inspection of Clavel Corporation on August 8, 2013 in Abilene, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 8, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Abilene, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |