FDA Inspection 778949 — Davion Inc
The FDA completed an inspection of Davion Inc on May 10, 2012 in Newark, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 10, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newark, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1977 | 21 CFR 211.182 | Dedicated equipment: records part of batch record |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |