FDA Inspection 785380 — Accra-Pac, Inc.
The FDA completed an inspection of Accra-Pac, Inc. on June 7, 2012 in Elkhart, IN. 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
- June 7, 2012
- Fiscal Year
- 2012
- 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 |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |