FDA Inspection
Lexamed, LtdLexamed, Ltd – FDA Inspection, Dec 6, 2018
Record Details
This FDA Inspection record concerns Lexamed, Ltd, with an inspection on December 6, 2018, issued by the Cincinnati District Office, covering human drugs.
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ID · ac414ff2-c5d3-4b44-bc7a-0ee04d90dbf8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073550
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)Scientifically sound laboratory controls
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Other FDA inspections of Lexamed, Ltd
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2026 | VAI | Cincinnati District Office | Drug Quality Assurance |
| August 4, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 5, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Lexamed, Ltd
- FDA Inspection 1328368 - 2026-07-09
- FDA Inspection 1176430 - 2022-08-04
- FDA Inspection 955062 - 2015-11-05
- FDA Inspection 572516 - 2009-03-13
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