FDA Inspection
Element Materials Technology Boston - Acton Inc.Element Materials Technology Boston - Acton Inc. – FDA Inspection, May 4, 2026
Record Details
This FDA Inspection record concerns Element Materials Technology Boston - Acton Inc., with an inspection on May 4, 2026, issued by the New England District Office, covering human drugs.
- Inspection Date
- May 4, 2026
- Product Type
- Human Drugs
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ID · 84d8d2e6-2a9c-438f-8dd3-82c170064476
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1316646
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.58Buildings not maintained in good state of repair
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Other FDA inspections of Element Materials Technology Boston - Acton Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | Not classified | New England District Office | Human Cellular, Tissue, and Gene Therapies |
| January 15, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 9, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 27, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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