FDA Inspection 1041963 — Coral Drugs Private Limited
The FDA completed an inspection of Coral Drugs Private Limited on February 23, 2018 in Rai. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 23, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rai (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |