FDA Inspection
Canadian Analytical Laboratories Inc.Canadian Analytical Laboratories Inc. – FDA Inspection, Mar 3, 2020
Record Details
This FDA Inspection record concerns Canadian Analytical Laboratories Inc., with an inspection on March 3, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- March 3, 2020
- Product Type
- Drugs
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ID · 47af38f1-9f92-4c40-896c-ebcfd9be3c6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1119571
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.68(b)Backup data not assured as exact and complete
- 21 CFR 211.194(b)Test method modification records do not include
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
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Other FDA inspections of Canadian Analytical Laboratories Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2025 | Not classified | Office of Inspections and Investigations | |
| May 19, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Canadian Analytical Laboratories Inc.
- FDA Inspection 1265803 - 2025-02-24
- FDA Inspection 1012539 - 2017-05-19
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