FDA Inspection 1080044 — Softgel Healthcare Private Limited
The FDA completed an inspection of Softgel Healthcare Private Limited on Feb 22, 2019 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 22, 2019
- Fiscal Year
- 2019
- 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 |
| 3558 | 21 CFR 211.52 | Washing and toilet facilities not provided and accessible |