FDA Inspection 1262422 — Softgel Healthcare Private Limited
The FDA completed an inspection of Softgel Healthcare Private Limited on Feb 14, 2025 in Pudupakkam, Kancheepuram. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Pudupakkam, Kancheepuram (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |