BPL Plasma, Inc. – FDA Inspection, Feb 2, 2018

Record Details

This FDA Inspection record concerns BPL Plasma, Inc., with an inspection on February 2, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: BPL Plasma, Inc.
Inspection Date: February 2, 2018
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
People: Elizabeth B. Griffin (FDA Associated Person)
Kathryn A. Krentz (Company Rep)

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ID · 57ad8a35-37d3-4425-ad5f-f7393d697abd

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1039470
FDA center: Biologics
Project area: Blood and Blood Products
Outcome: Form 483 issued

FDA Citations

21 CFR 600.14(c)When to report
21 CFR 610.47(a)Lookback System [Collecting Establishment]
21 CFR 606.100(c)Thorough investigations

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FDA Inspection

BPL Plasma, Inc.February 2, 2018