FDA Inspection 1253815 — Shilpa Medicare Limited
The FDA completed an inspection of Shilpa Medicare Limited on Oct 30, 2024 in Dabaspet, Bengaluru. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 30, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dabaspet, Bengaluru (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |