FDA Inspection 996404 — FujiFilm Ultra Pure Solutions, Inc.
The FDA completed an inspection of FujiFilm Ultra Pure Solutions, Inc. on January 12, 2017 in Carrollton, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 12, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Carrollton, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1890 | 21 CFR 211.165(e) | Test methods |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |