FDA Inspection 760080 — Clavel Corporation
The FDA completed an inspection of Clavel Corporation on December 22, 2011 in Abilene, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 22, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Abilene, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |