FDA Inspection 1011854 — NATCO Pharma Limited
The FDA completed an inspection of NATCO Pharma Limited on January 24, 2017 in Rangareddy. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 24, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rangareddy (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1419 | 21 CFR 211.42(c)(8) | Released Drug Products Area |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 8906 | 21 CFR 314.81(b)(1)(i) | Mix-up |