Patheon Manufacturing Services LLCSeptember 12, 2014

FDA 483 - Patheon Manufacturing Services LLC - September 12, 2014

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Record Details

Patheon Manufacturing Services, LLC, a sterile drug manufacturer in Greenville, NC, was inspected by the FDA from September 9-12, 2014, and received four observations. The inspection revealed deficiencies in aseptic processing area cleaning, equipment sanitization, environmental monitoring, and sterility testing procedures. These issues indicate a moderate level of concern regarding the firm's control over its sterile manufacturing processes.

Company: Patheon Manufacturing Services LLC
Inspection Date: September 12, 2014
Product Type: Drugs
Office: Atlanta District Office
People: Rhonda Alexander (investigator)
Tamara A. Stephens
Seneca D. Toms

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ID · 79b91b77-43a2-4173-98dc-9cfaa27a6e92