PETNET Solutions Inc.July 28, 2021

FDA 483 - PETNET Solutions Inc. - July 28, 2021

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Record Details

PETNET Solutions Inc. in Woburn, MA, a PET drug manufacturer, was cited for failing to implement adequate procedures for equipment cleaning and suitability. Inspectors observed unknown particulate matter in critical aseptic processing areas and noted that transport containers for sterility testing were not cleaned or disinfected, raising concerns about potential contamination and product quality.

Company: PETNET Solutions Inc.
Inspection Date: July 28, 2021
Product Type: Drugs
Office: Division of Northeast Imports
People: Samir C. Gala (Drug Investigator)
Sean R. Marciisin

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ID · 3d90e764-2182-4fae-be67-1f3ae5f3b194