FDA Inspection 1076889 — LUPIN LIMITED
The FDA completed an inspection of LUPIN LIMITED on January 18, 2019 in Navi Mumbai. 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
- January 18, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Navi Mumbai (India)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6829 | 21 CFR 314.80(c)(2) | Failure to report non-alert ADEs |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |