483
Rebel Converting, LLCRebel Converting, LLC – FDA 483, Feb 24, 2024
Record Details
Rebel Converting LLC, a manufacturer in Milwaukee, WI, was cited for significant deficiencies in its quality control unit and manufacturing processes for OTC monograph drug products, particularly Benzalkonium Chloride wipes. The inspection revealed issues with product testing, stability data, hold time studies, component identity verification, and overall quality unit oversight, indicating a lack of control over product identity, strength, quality, and purity.
- Person
View Company Profile
ID · ab40cdf2-d4f9-4af0-9829-1418d6c78752
Other documents for Rebel Converting, 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.