FDA Inspection 1116358 — Person & Covey Inc
The FDA completed an inspection of Person & Covey Inc on January 30, 2020 in Glendale, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 30, 2020
- Fiscal Year
- 2020
- 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 |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1927 | 21 CFR 211.166(b) | Accelerated stability studies |
| 1958 | 21 CFR 211.180(f) | Responsible firm officials notified in writing |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |