Aphena Pharma Solutions-Maryland LLCDecember 15, 2021

FDA 483 - Aphena Pharma Solutions-Maryland LLC - December 15, 2021

Record Details

Aphena Pharma Solutions-Maryland LLC was inspected from December 7-15, 2021, revealing significant deficiencies in quality control, manufacturing, and facility maintenance. The inspection found failures in OOS investigations, inadequate laboratory controls, improper storage conditions, and unsanitized equipment, indicating a lack of adherence to cGMP regulations.

Company: Aphena Pharma Solutions-Maryland LLC
Inspection Date: December 15, 2021
Product Type: Drugs
Office: Office of Regulatory Affairs
People: Juliana M. Badalucco (investigator)
Roseline N. Boateng
Mindy M. Chou

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ID · 674e88d8-0d68-4b93-9428-5a000a4eb40d