Lincare Inc. – FDA Inspection, Dec 18, 2015

Record Details

This FDA Inspection record concerns Lincare Inc., with an inspection on December 18, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Lincare Inc.
Inspection Date: December 18, 2015
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · e6f8e4a6-9046-42f0-a40f-3726b7814bbe

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 956001
FDA center: Human Drugs
Project area: Drug Quality Assurance

FDA Citations

21 CFR 211.137(a)Expiration date lacking
21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.188(b)(8)Labeling Control Records and Label Copies

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FDA Inspection

Lincare Inc.December 18, 2015