FDA Inspection
Diversey Canada, Inc.Diversey Canada, Inc. – FDA Inspection, Apr 22, 2016
Record Details
This FDA Inspection record concerns Diversey Canada, Inc., with an inspection on April 22, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Diversey Canada, Inc.
- Inspection Date
- April 22, 2016
- Product Type
- Drugs
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ID · fd60f554-aa34-488a-9ee1-3efae5f0aeea
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 973072
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
FDA Citations
9- 21 CFR 211.196Distribution Record Requirements
- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.122(g)Failure to include one of special control procedures
- 21 CFR 211.166(a)(2)Stability sample storage conditions described
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.198(a)Complaints reviewed by Quality Control Unit
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Diversey Canada, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 9, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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