FDA Inspection 1260896 — Person & Covey Inc
The FDA completed an inspection of Person & Covey Inc on February 6, 2025 in Glendale, CA. 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
- February 6, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Glendale, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |