483
API Solutions Inc.API Solutions Inc. – FDA 483, Apr 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.
View Company Profile
ID · 2571d7a6-87bc-408c-8853-d8379923eb25
Other documents for API Solutions Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.