FDA Inspection 788005 — Teva Womens Health, LLC
The FDA completed an inspection of Teva Womens Health, LLC on Jun 4, 2012 in Cincinnati, OH. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 4, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cincinnati, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1164 | 21 CFR 211.28(c) | Unauthorized Personnel in Limited Access Areas |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |