483
International Trading Pharm Lab IncFDA 483 - International Trading Pharm Lab Inc - September 16, 2021
Discuss this record with AI
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.
Record Details
An FDA inspection of International Trading Pharm Lab Inc. in Paterson, NJ, revealed significant deficiencies in their control testing laboratory. The firm failed to thoroughly investigate out-of-specification results and lacked scientifically sound test procedures for assuring drug product quality. These issues indicate a serious breakdown in quality control and data integrity within their analytical operations.
Open in Dashboard
ID · ba06956f-e3ab-44bb-aa56-41131a5a1b99