Fairview Compounding Phamacy – FDA Inspection, Apr 18, 2018

Record Details

This FDA Inspection record concerns Fairview Compounding Phamacy, with an inspection on April 18, 2018, issued by the Minneapolis District Office, covering human drugs.

Company: Fairview Compounding Phamacy
Inspection Date: April 18, 2018
Product Type: Human Drugs
Office: Minneapolis District Office
People: Anthony J. Ladner (FDA Associated Person)
Tenzin Jangchup (FDA Associated Person)

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ID · 909c7fb6-3cf9-4add-a075-5fe744528219

Inspection Facts

Inspection number: 1048624
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
FDCA 501(a)(2)(A)Inadequate sporicidal agents, cleanroom and ISO 5 area
FDCA 501(a)(2)(A)Non-sterilized and non-depyrogenated, sterile drug
FDCA 501(a)(2)(A)Personnel habits, contamination

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FDA Inspection

Fairview Compounding PhamacyApril 18, 2018