483
Aphena Pharma Solutions-Maryland LLCFDA 483 - Aphena Pharma Solutions-Maryland LLC - December 15, 2021
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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.
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ID · 674e88d8-0d68-4b93-9428-5a000a4eb40d