FDA Inspection
Element Materials Technology Bend, LLCElement Materials Technology Bend, LLC – FDA Inspection, Nov 16, 2018
Record Details
This FDA Inspection record concerns Element Materials Technology Bend, LLC, with an inspection on November 16, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 25bd336c-a36b-4aba-9f6c-f483c76b8bbc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1072026
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(a)Deviations from laboratory control requirements
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Other FDA inspections of Element Materials Technology Bend, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 20, 2025 | VAI | Seattle District Office | Drug Quality Assurance |
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