483
AMWARE FULFILLMENT SERVICES INCFDA 483 - AMWARE FULFILLMENT SERVICES INC - June 22, 2023
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
AMWARE FULFILLMENT SERVICES INC, a repacker/relabeler in Dayton, NJ, was cited by the FDA for significant deficiencies in its operations. The inspection revealed that employees involved in repackaging OTC drug products had not received appropriate Good Manufacturing Practices (GMP) training. Furthermore, the firm failed to establish necessary GMP procedures since the commencement of these repackaging activities.
Open in Dashboard
ID · c9ec2a5b-4cfd-4526-bca7-eb7682a0bd28