Lex, Inc. – FDA Inspection, Sep 16, 2013

Record Details

This FDA Inspection record concerns Lex, Inc., with an inspection on September 16, 2013, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company: Lex, Inc.
Inspection Date: September 16, 2013
Product Type: Food/cosmetics
Office: Center for Food Safety and Applied Nutrition

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ID · 8ed9780a-0170-4cd2-bf13-f44d67a6b100

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 848516
FDA center: Foods & Cosmetics
Project area: Food Composition, Standards, Labeling and Econ

FDA Citations

21 CFR 211.25(a)GMP Training Frequency
21 CFR 211.84(d)(2)Reports of Analysis (Components)
21 CFR 211.100(a)Absence of Written Procedures
21 CFR 211.166(a)Written program not followed
21 CFR 211.180(e)(1)Review of representative number of batches
21 CFR 111.70(e)Specifications - identity, purity, strength, composition
21 CFR 111.75(a)(2)(ii)(A)Component - qualify supplier

Full citation text and observation details available on the Dashboard.

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
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