FDA Inspection
HK Kolmar Canada, Inc.HK Kolmar Canada, Inc. – FDA Inspection, Jun 5, 2025
Record Details
This FDA Inspection record concerns HK Kolmar Canada, Inc., with an inspection on June 5, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · d07731bc-df43-43b5-9610-277a214a802e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271803
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.180(e)Records reviewed annually
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Other FDA inspections of HK Kolmar Canada, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 21, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 20, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for HK Kolmar Canada, Inc.
- FDA Inspection 1114552 - 2019-11-01
- FDA Inspection 1027545 - 2017-09-29
- FDA Inspection 940515 - 2015-08-21
- FDA Inspection 853300 - 2013-09-20
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