FDA Inspection 1273696 — GAYATRI AYUPHARMA PVT LTD
The FDA completed an inspection of GAYATRI AYUPHARMA PVT LTD on June 24, 2025 in Chandial. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 24, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chandial (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15696 | 21 CFR 111.315(e) | Examination, testing; established criteria |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |