Lex, Inc. – FDA Inspection, Mar 1, 2011

Record Details

This FDA Inspection record concerns Lex, Inc., with an inspection on March 1, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Lex, Inc.
Inspection Date: March 1, 2011
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · ea445091-f7bc-4830-9db4-ef0ed17369a5

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 707801
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 111.560(a)(2)Product complaint - quality control investigate
21 CFR 211.180(e)Records reviewed annually
21 CFR 211.84(d)(2)Reports of Analysis (Components)
21 CFR 211.65(b)Substances That Come in Contact
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.122(a)Written procedures describing in detail
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier
21 CFR 111.75(c)Specifications met - verify; finished batch
21 CFR 111.105(b)Quality control - supplier qualification

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Other FDA inspections of Lex, Inc.

Date	Classification	Office	Project area
February 28, 2023	OAI	Center for Drug Evaluation and Research	Drug Quality Assurance
February 14, 2018	VAI	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
September 28, 2010	NAI	Center for Food Safety and Applied Nutrition	Food Composition, Standards, Labeling and Econ