Aphena Pharma Solutions-Maryland LLCMay 6, 2022

FDA 483 - Aphena Pharma Solutions-Maryland LLC - May 06, 2022

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Record Details

Aphena Pharma Solutions-Maryland LLC in Easton, MD, was cited for significant deficiencies during an FDA inspection. Observations included inadequate equipment qualification for a blend tank, failures to thoroughly investigate unexplained discrepancies in batch records, and incomplete master production and control records. These issues indicate a lack of robust quality control and process validation in drug product manufacturing.

Company: Aphena Pharma Solutions-Maryland LLC
Inspection Date: May 6, 2022
Product Type: Drugs
Office: Office of Regulatory Affairs
People: Brandy N. Lepage (Consumer Safety Officer)
Sena G. Dissmeyer

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ID · cfd0c893-ad89-4c7e-a863-f1bca8609f53