FDA Inspection 794472 — Lotte Biologics USA, LLC
The FDA completed an inspection of Lotte Biologics USA, LLC on July 20, 2012 in East Syracuse, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- East Syracuse, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 15706 | 21 CFR 111.325(a) | Laboratory operations: electronic |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |