FDA Inspection 1025819 — Patcos Cosmetics (India) Private Limited
The FDA completed an inspection of Patcos Cosmetics (India) Private Limited on Sep 20, 2017 in Daman. 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Daman (India)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 3557 | 21 CFR 211.52 | Washing and toilet facilities are deficient |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |