FDA Inspection 826944 — Teva Puerto Rico LLC
The FDA completed an inspection of Teva Puerto Rico LLC on April 11, 2013 in Fajardo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fajardo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1218 | 21 CFR 211.67(b)(1) | Cleaning SOP/responsibility |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |