PANROSA ENTERPRISE INC. – FDA Inspection, Dec 18, 2018

Record Details

This FDA Inspection record concerns PANROSA ENTERPRISE INC., with an inspection on December 18, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: PANROSA ENTERPRISE INC.
Inspection Date: December 18, 2018
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Bryan A. Galvez (FDA Associated Person)

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ID · 676b73b8-d0e9-45e2-ba8e-67b9739abfcb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1075081
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.160(b)Scientifically sound laboratory controls
21 CFR 211.165(e)Test methods
21 CFR 211.188(b)Batch production and Batch Control Record Requirements
21 CFR 211.166(a)(3)Valid stability test methods

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FDA Inspection

PANROSA ENTERPRISE INC.December 18, 2018