483
P & L Development, LLCFDA 483 - P & L Development, LLC - November 13, 2018
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 R & S Developments, LLC in Westbury, NY, a drug packager/relabeler, revealed significant deficiencies. The firm failed to implement adequate line clearance processes, resulting in numerous complaints of foreign drug product contamination. Additionally, laboratory records for stability data review were found to be deficient, impacting critical product information.
Open in Dashboard
ID · fe8b19d2-d4d3-4020-813d-3dc607afa458