FDA Inspection
Teva Canada LimitedTeva Canada Limited – FDA Inspection, Apr 24, 2025
Record Details
This FDA Inspection record concerns Teva Canada Limited, with an inspection on April 24, 2025, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 96138a9e-ce2b-4f51-9172-f88b575da179
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1265556
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Teva Canada Limited
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 18, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 21, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teva Canada Limited
- FDA Inspection 1092488 - 2019-04-26
- FDA Inspection 992270 - 2016-11-18
- FDA Inspection 868166 - 2014-02-21
- FDA Inspection 750624 - 2011-09-29
- FDA Inspection 680578 - 2010-07-29
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