FDA Inspection 1202446 — Balassa Laboratories
The FDA completed an inspection of Balassa Laboratories on April 7, 2023 in Port Orange, FL. 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
- April 7, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Orange, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |