FDA Inspection 827465 — Taro Pharmaceuticals U.S.A., Inc.
The FDA completed an inspection of Taro Pharmaceuticals U.S.A., Inc. on Apr 18, 2013 in Hawthorne, NY. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 18, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hawthorne, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6823 | 21 CFR 314.80(c) | Failure by applicant to report ADE |