Sterling Pharmaceutical Services LLCFebruary 18, 2022

FDA 483 - Sterling Pharmaceutical Services LLC - February 18, 2022

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Sterling Pharmaceutical Services LLC, a sterile ophthalmic drug manufacturer in Dupo, IL, received a Form 483 with four observations. The inspection revealed significant deficiencies in aseptic processing validation, quality control unit procedures, investigation of discrepancies, and adherence to contamination prevention procedures. These issues indicate a systemic lack of control over sterile manufacturing processes.

Company: Sterling Pharmaceutical Services LLC
Inspection Date: February 18, 2022
Product Type: Drugs
Office: Chicago District Office
People: Michael Zubelewicz
Wayne D. Mcgrath

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ID · 923798f7-0472-4daf-84cc-57871eadd827