Aspen SA Sterile Operations (Pty) Ltd.December 4, 2018

FDA 483 - Aspen SA Sterile Operations (Pty) Ltd. - December 04, 2018

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Record Details

Aspen SVP Pty Ltd. in Port Elizabeth, South Africa, was cited for significant deficiencies in its manufacturing processes for sterile drug products. The inspection revealed widespread issues with aseptic techniques, quality control unit oversight, laboratory controls, and facility maintenance, indicating a systemic failure to prevent contamination and ensure product quality.

Company: Aspen SA Sterile Operations (Pty) Ltd.
Inspection Date: December 4, 2018
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Cheryl A. Clausen
Michael R. Shanks (Investigator)

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ID · e74bd9a0-bd9d-4483-bb71-66c2f704eee3