FDA Inspection 1211415 — Marksans Pharma Limited
The FDA completed an inspection of Marksans Pharma Limited on August 4, 2023 in Verna. 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
- August 4, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Verna (India)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6705 | 21 CFR 310.305(c) | Failure to submit ADE report |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |