FDA Inspection 1094299 — Kremoint Pharma Private Limited
The FDA completed an inspection of Kremoint Pharma Private Limited on June 20, 2019 in Mumbai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mumbai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |