FDA Inspection 1232979 — K.W. Griffen Company
The FDA completed an inspection of K.W. Griffen Company on March 15, 2024 in Norwalk, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Norwalk, CT (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6730 | 21 CFR 314.80(b) | Failure to develop written procedures |
| 6830 | 21 CFR 314.80(c)(2) | Interval |
| 6833 | 21 CFR 314.80(c)(2)(ii)(A) | Incomplete periodic safety report |
| 6842 | 21 CFR 314.80(j) | Failure to maintain records |
| 8912 | 21 CFR 314.81(b)(2) | Timely submission |