Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy) – FDA Inspection, Aug 16, 2019

Record Details

This FDA Inspection record concerns Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy), with an inspection on August 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy)
Inspection Date: August 16, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Joshua P. Wireman (FDA Associated Person)

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ID · 45bf2d6e-b484-41c1-a6d8-88dea49eb175

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1100402
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued
Enforcement: 483 Response

FDA Citations

FDCA 501(a)(2)(A)Hazardous drugs, prevention of cross-contamination
FDCA 501(a)(2)(A)Air flow quality, higher classified area

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FDA Inspection

Columbia River Pharmacy LLC (DBA Malley's Compounding Pharmacy)August 16, 2019