FDA Inspection 1159287 — Valgene Incorporated dba Cape Drugs
The FDA completed an inspection of Valgene Incorporated dba Cape Drugs on December 2, 2021 in Annapolis, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 2, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Annapolis, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18956 | FDCA 501(a)(2)(A) | Cleanliness, ISO-classified areas |
| 18961 | FDCA 501(a)(2)(A) | Air flow quality, higher classified area |
| 21284 | FDCA 501(a)(2)(A) | Disinfectant contact time |