FDA Inspection 904407 — Accra-Pac, Inc.
The FDA completed an inspection of Accra-Pac, Inc. on November 21, 2014 in Elkhart, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 21, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Elkhart, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1384 | 21 CFR 211.101(c) | Weighing/measuring/subdividing supervision |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |