483
API Solutions Inc.FDA 483 - API Solutions Inc. - April 10, 2019
Record Details
APT Solutions Inc., a relabeler in Daphne, AL, received two observations during an FDA inspection. The firm failed to ensure that each lot of components was withheld from use until sampled, tested, examined, and released by the quality control unit. Additionally, there was no written testing program in place to assess the stability characteristics of drug products.
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ID · 2571d7a6-87bc-408c-8853-d8379923eb25