FDA Inspection 719132 — Accupac, Inc.
The FDA completed an inspection of Accupac, Inc. on April 14, 2011 in Lansdale, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lansdale, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 8911 | 21 CFR 314.81(b)(1)(ii) | Failure to meet specifications |