FDA Inspection 1021645 — Global Health Solutions LLC dba Turn Therapeutics
The FDA completed an inspection of Global Health Solutions LLC dba Turn Therapeutics on August 14, 2017 in Westlake Village, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
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 |