FDA Inspection 1282006 — OmniActive Health Technologies
The FDA completed an inspection of OmniActive Health Technologies on September 17, 2025 in Kelamangalam. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 17, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Kelamangalam (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 18142 | 21 CFR 117.35(a) | Sanitary operations - Plant sanitation |
| 18149 | 21 CFR 117.40 | Equipment and utensils - Design and maintenance |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 22718 | 21 CFR 117.135(c)(1) | Process preventive controls - Appropriate (Adequate) |