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

An FDA inspection of Aphena Pharma Solutions-Maryland LLC was conducted from December 7-15, 2021, focusing on drug manufacturing and pre-approval readiness under CPGM 7356.002 and 7346.832. The inspection found significant quality control deficiencies, resulting in an eight-item Form FDA 483 and several verbal observations.

Key violations included a failure to thoroughly investigate discrepancies and batch failures, inadequate laboratory controls for sampling and testing, and insufficient segregation to prevent contamination during packaging. The firm also failed to store drug products and materials under appropriate temperature/humidity conditions and did not ensure proper cleaning and sanitation of equipment. Furthermore, the quality control unit did not consistently follow its procedures, buildings were not maintained, and annual batch record evaluations lacked proper adherence to written procedures.

Other issues highlighted included undocumented actions for deviations, incomplete temperature mapping studies, and unvalidated analytical practices. The firm released bulk drug products without identity testing and lacked comprehensive quality agreements for certain packaging materials.

Aphena Pharma Solutions-Maryland LLC was required to submit a written response to the FDA 483 within 15 business days. Management was also reminded that distributing drug products without completed process validation could deem them adulterated, and that electronic laboratory records require thorough review. The acceptability of pending ANDAs will be determined by CDER based on these findings.