FDA Inspection 827113 — ABBE Laboratories, Inc.
The FDA completed an inspection of ABBE Laboratories, Inc. on April 12, 2013 in Farmingdale, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 2003 | 21 CFR 211.184(c) | Individual inventory record |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4320 | 21 CFR 211.84(d)(6) | Microbiological Contamination Exam |
| 4350 | 21 CFR 211.160(b)(3) | Drug products-sampling procedures/specifications |