FDA Inspection
Whisk Products IncWhisk Products Inc – FDA Inspection, Oct 22, 2021
Record Details
This FDA Inspection record concerns Whisk Products Inc, with an inspection on October 22, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Whisk Products Inc
- Inspection Date
- October 22, 2021
- Product Type
- Drugs
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ID · 7cbb6a03-e9c2-41db-8b60-75e609fd8ac5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155133
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Whisk Products Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2026 | Not classified | Kansas City District Office | Drug Quality Assurance |
| April 26, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 18, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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