Mayo Clinic Pharmacy – FDA Inspection, Aug 15, 2018

Record Details

This FDA Inspection record concerns Mayo Clinic Pharmacy, with an inspection on August 15, 2018, issued by the Minneapolis District Office, covering human drugs.

Company: Mayo Clinic Pharmacy
Inspection Date: August 15, 2018
Product Type: Human Drugs
Office: Minneapolis District Office
People: James K. Ireland (FDA Associated Person)
Tenzin Jangchup (FDA Associated Person)

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ID · 583d75d4-9a5f-4cd6-a654-0f39464e283b

Inspection Facts

Inspection number: 1062834
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

FDCA 501(a)(2)(A)Actionable microbial contamination, ISO 5 area
FDCA 501(a)(2)(A)Disinfectant contact time
FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
FDCA 501(a)(2)(A)Non-microbial contamination, production area

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FDA Inspection

Mayo Clinic PharmacyAugust 15, 2018