FDA Inspection 876075 — Balassa Laboratories
The FDA completed an inspection of Balassa Laboratories on April 25, 2014 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). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Orange, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |