FDA Inspection 653626 — ABBE Laboratories, Inc.
The FDA completed an inspection of ABBE Laboratories, Inc. on Mar 23, 2010 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
- Mar 23, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |