FDA Inspection 636239 — Teva Puerto Rico LLC
The FDA completed an inspection of Teva Puerto Rico LLC on December 29, 2009 in Fajardo, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 29, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fajardo, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |