483
LBB Specialties Holdings LLCLBB Specialties Holdings LLC – FDA 483, Jun 26, 2019
Record Details
An FDA inspection of American International Chemical, LLC in Framingham, MA, in June 2019, revealed inadequate quality oversight concerning drug products. The firm distributed out-of-specification Urea, USP, and failed to conduct a thorough investigation into the product quality and potential impact of the impurity. This indicates a significant lapse in quality control for distributed drug products.
View Company Profile
ID · abec0deb-2306-4094-ab3f-668586677308
Other documents for LBB Specialties Holdings LLC
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.