FDA Inspection 903724 — Brisar Industries, Inc.
The FDA completed an inspection of Brisar Industries, Inc. on November 20, 2014 in Paterson, NJ. 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
- November 20, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Paterson, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 15456 | 21 CFR 111.20(b) | Physical plant - space; equipment, materials |
| 15878 | 21 CFR 111.75(e) | Product - visually examine, identified |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |