FDA 483 - Advance Pharmaceutical Inc - February 27, 2025
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 Advance Pharmaceutical Inc, an OTC drug manufacturer in Holtsville, NY, revealed significant deficiencies in quality unit oversight and control. Observations included failures to monitor storage temperatures for laboratory reference standards, improper handling and storage of raw materials leading to contamination risks, and inadequate storage of in-process materials in an unsecured area. These issues indicate a lack of adherence to established standards for ensuring product quality and preventing contamination.
ID · 15ce1760-e850-4913-a24a-68fd99f87462