FDA Inspection
Lex, Inc.Lex, Inc. – FDA Inspection, Feb 14, 2018
Record Details
This FDA Inspection record concerns Lex, Inc., with an inspection on February 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9db0112a-a335-403f-bfa3-da496c4387e7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041092
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.194(a)(2)Test methods ID and data location
- 21 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Lex, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 28, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 20, 2016 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 16, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| March 1, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2010 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
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