1021645
Global Health Solutions LLC dba Turn Therapeutics — FEI 3012147657
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 14, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Westlake Village, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1418 | 21 CFR 211.42(c)(7) | Quarantined Drug Products Area |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3639 | 21 CFR 211.204 | Returned drug procedures in writing and followed |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4388 | 21 CFR 211.198(a) | Complaints reviewed by Quality Control Unit |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |