FDA Inspection
Element Materials Technology Canada Inc.Element Materials Technology Canada Inc. – FDA Inspection, Oct 18, 2019
Record Details
This FDA Inspection record concerns Element Materials Technology Canada Inc., with an inspection on October 18, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 18, 2019
- Product Type
- Drugs
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ID · 5a70da90-5af9-460e-b1f7-9d8977667ba1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1106890
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Element Materials Technology Canada Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| January 22, 2025 | Not classified | Office of Inspections and Investigations | |
| September 15, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 9, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 6, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 29, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Element Materials Technology Canada Inc.
- FDA Inspection 1258899 - 2025-01-22
- FDA Inspection 1027543 - 2017-09-15
- FDA Inspection 918934 - 2015-02-09
- FDA Inspection 812738 - 2012-12-06
- FDA Inspection 610534 - 2009-07-29
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