FDA Inspection 1332070 — Balassa Laboratories, Inc
The FDA completed an inspection of Balassa Laboratories, Inc on Aug 21, 2026 in Port Orange, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 21, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Port Orange, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4511 | 21 CFR 108.25(f) | Approved school |