Roger Williams Medical Center – FDA Inspection, Aug 14, 2019

Record Details

This FDA Inspection record concerns Roger Williams Medical Center, with an inspection on August 14, 2019, issued by the New England District Office, covering human drugs.

Company: Roger Williams Medical Center
Inspection Date: August 14, 2019
Product Type: Human Drugs
Office: New England District Office
People: Jonah S. Ufferfilge (FDA Associated Person)
Jonathan G. Matrisciano (FDA Associated Person)

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ID · a35475dd-f007-4648-beda-12ee88544fcb

Inspection Facts

Inspection number: 1100695
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

FDCA 501(a)(2)(A)Actionable microbial contamination, adjacent area
FDCA 501(a)(2)(A)Air flow quality, higher classified area
FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
FDCA 501(a)(2)(A)Flow of personnel and materials, facility
FDCA 501(a)(2)(A)Inadequate sporicidal agents, cleanroom and ISO 5 area

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FDA Inspection

Roger Williams Medical CenterAugust 14, 2019