FDA Inspection 1300978 — MEGHMANI LLP
The FDA completed an inspection of MEGHMANI LLP on February 3, 2026 in Dahej. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dahej (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 3610 | 21 CFR 211.160(b)(3) | Drug product sample |