FDA Inspection
Element Materials Technology Midland Inc.Element Materials Technology Midland Inc. – FDA Inspection, May 23, 2024
Record Details
This FDA Inspection record concerns Element Materials Technology Midland Inc., with an inspection on May 23, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 7fc29b4f-471e-4fad-8043-ec9aef4b1f2a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1239251
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.194(a)(2)Test methods ID and data location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Element Materials Technology Midland Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 12, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 14, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 19, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Element Materials Technology Midland Inc.
- FDA Inspection 995072 - 2016-11-18
- FDA Inspection 790418 - 2012-07-12
- FDA Inspection 701252 - 2010-12-14
- FDA Inspection 631221 - 2009-11-19
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