FDA Inspection
Labomar Canada IncLabomar Canada Inc – FDA Inspection, Aug 13, 2009
Record Details
This FDA Inspection record concerns Labomar Canada Inc, with an inspection on August 13, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Labomar Canada Inc
- Inspection Date
- August 13, 2009
- Product Type
- Drugs
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ID · dcb14cd4-103d-49f5-b2ac-a68706217264
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 605450
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.130(b)Unlabeled filled containers controls
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Labomar Canada Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 9, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 15, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 5, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 2, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Labomar Canada Inc
- FDA Inspection 1249452 - 2024-08-09
- FDA Inspection 1073370 - 2018-11-09
- FDA Inspection 998477 - 2016-12-15
- FDA Inspection 887471 - 2014-06-05
- FDA Inspection 763073 - 2011-12-02
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