FDA Inspection 1062093 — K.W. Griffen Company
The FDA completed an inspection of K.W. Griffen Company on August 14, 2018 in Norwalk, CT. 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
- August 14, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Norwalk, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3623 | 21 CFR 211.170(a) | Active ingredient retained sample kept |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |