FDA Inspection
Element Materials Technology Ann Arbor, LLCElement Materials Technology Ann Arbor, LLC – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Element Materials Technology Ann Arbor, LLC, with an inspection on March 22, 2018, issued by the Detroit District Office, covering human drugs.
- Inspection Date
- March 22, 2018
- Product Type
- Human Drugs
- Office
- Detroit District Office
- Person
- Emily J. Stoklosa (Issuing Officer)
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ID · d74091aa-8915-4d40-8294-cb4bdd82edfa
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1045666
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Element Materials Technology Ann Arbor, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 23, 2026 | Not classified | Detroit District Office | |
| September 9, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 30, 2018 | Not classified | Detroit District Office | |
| June 28, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Element Materials Technology Ann Arbor, LLC
- FDA Inspection 1308966 - 2026-02-23
- FDA Inspection 1179195 - 2022-09-09
- FDA Inspection 1073160 - 2018-10-30
- FDA Inspection 978217 - 2016-06-28
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