FDA Inspection 862373 — Davion Inc
The FDA completed an inspection of Davion Inc on January 22, 2014 in Newark, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 22, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Newark, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1049 | 21 CFR 211.22(a) | Approve or reject components, products |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1912 | 21 CFR 211.166(a) | Written program not followed |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |