Beau. Beau. Corp. – FDA Inspection, Jul 14, 2017

Record Details

This FDA Inspection record concerns Beau. Beau. Corp., with an inspection on July 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Beau. Beau. Corp.
Inspection Date: July 14, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Emilie Kahn (Issuing Officer)

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ID · 6f75720c-efcf-465e-a7ce-747f0708a4ba

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1017853
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.46(b)Equipment for Environmental Control
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.67(b)Written procedures not established/followed

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FDA Inspection

Beau. Beau. Corp.July 14, 2017