FDA 483 - Cross Brands Contract Filling, LLC - June 10, 2019
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.
An FDA inspection of Cross-Brands Manufacturing LLC in Rockledge, FL, an OTC drug product manufacturer, revealed numerous significant deficiencies in its quality control unit and manufacturing processes. The firm failed to establish and follow written procedures for critical operations, including component testing, microbial control, equipment cleaning, and product release. These widespread issues indicate a severe lack of adherence to Good Manufacturing Practices, posing potential risks to the quality and safety of their OTC drug products.
- Office
- Dallas District Office
- Person
ID · 1f12adcb-6257-4b1d-a613-9711f5bfb404