483
Aphena Pharma Solutions-Maryland LLCAphena Pharma Solutions-Maryland LLC – FDA 483, May 6, 2022
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.
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ID · cfd0c893-ad89-4c7e-a863-f1bca8609f53
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