FDA Inspection 1235038 — Emcure Pharmaceuticals Limited
The FDA completed an inspection of Emcure Pharmaceuticals Limited on April 5, 2024 in Ahmedabad. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 5, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Ahmedabad (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |