FDA Inspection 1155133 — Whisk Products Inc
The FDA completed an inspection of Whisk Products Inc on October 22, 2021 in Wentzville, MO. 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
- October 22, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Wentzville, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |