FDA Inspection 769594 — Taro Pharmaceuticals U.S.A., Inc.
The FDA completed an inspection of Taro Pharmaceuticals U.S.A., Inc. on Mar 8, 2012 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 8, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hawthorne, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6840 | 21 CFR 314.80(f)(1) | Wrong form - domestic ADE |