BEC Chemicals Private Limited – FDA Inspection, Dec 8, 2017

Record Details

This FDA Inspection record concerns BEC Chemicals Private Limited, with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: BEC Chemicals Private Limited
Inspection Date: December 8, 2017
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Andrew J. Idzior (FDA Associated Person)

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ID · b0ab9ccd-db3e-4be7-9aa4-6113675a617e

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1034203
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.160(b)Scientifically sound laboratory controls

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FDA Inspection

BEC Chemicals Private LimitedDecember 8, 2017