Peer Pharm Ltd. – FDA Inspection, Sep 11, 2019

Record Details

This FDA Inspection record concerns Peer Pharm Ltd., with an inspection on September 11, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Peer Pharm Ltd.
Inspection Date: September 11, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Michael E. Maselli (Company Rep)
Rachael A. Moss (Issuing Officer)

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ID · f04304f4-ae46-4d58-ad9e-a2752e14c74f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1101629
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.110(a)Control procedures to monitor and validate performance
21 CFR 211.165(b)Microbiological testing
21 CFR 211.84(c)(4)Top/Middle/Bottom container sampling
21 CFR 211.188(b)Batch production and Batch Control Record Requirements
21 CFR 211.84(d)(1)Identity Testing of Each Component
21 CFR 211.166(a)Lack of written stability program
21 CFR 211.180(e)(2)Items to cover on annual reviews

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FDA Inspection

Peer Pharm Ltd.September 11, 2019