FDA Inspection 592198 — Taro Pharmaceuticals U.S.A., Inc.
The FDA completed an inspection of Taro Pharmaceuticals U.S.A., Inc. on May 29, 2009 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
- May 29, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hawthorne, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 6728 | 21 CFR 314.80(b) | Failure to review ADE information |
| 6732 | 21 CFR 314.80(c)(1)(i) | Late submission of 15-day report |
| 6831 | 21 CFR 314.80(c)(2) | Late submission of quarterly safety reports |