FDA Inspection 796841 — Bioanue Laboratories Inc.
The FDA completed an inspection of Bioanue Laboratories Inc. on August 24, 2012 in Rochelle, GA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 24, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rochelle, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15406 | 21 CFR 111.13(b) | Supervisor - education, training |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |