FDA Inspection 1049200 — Balassa Laboratories
The FDA completed an inspection of Balassa Laboratories on April 23, 2018 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 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Orange, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |