FDA Inspection 614146 — ABBE Laboratories, Inc.
The FDA completed an inspection of ABBE Laboratories, Inc. on Sep 25, 2009 in Farmingdale, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 25, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3569 | 21 CFR 211.89 | Quarantine of Rejected Components et. al. |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |