FDA Inspection 1231630 — Bafna Enterprises
The FDA completed an inspection of Bafna Enterprises on Mar 1, 2024 in Kochi. 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
- Mar 1, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kochi (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 18149 | 21 CFR 117.40 | Equipment and utensils - Design and maintenance |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 19084 | 21 CFR 117.305 | Preventive controls records - General requirements |
| 21399 | 21 CFR 117.80(b)(3) | Raw materials controls - Natural toxins |
| 22703 | 21 CFR 117.135(a)(1) | Process preventive controls - Implement |
| 22705 | 21 CFR 117.135(a)(1) | Allergen preventive controls - Identify (Written) |
| 22714 | 21 CFR 117.410(c) | Supply-chain program - Assurance (Adequate) |