FDA Inspection 563376 — Actavis Totowa LLC
The FDA completed an inspection of Actavis Totowa LLC on March 31, 2009 in Little Falls, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 31, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Little Falls, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1912 | 21 CFR 211.166(a) | Written program not followed |