FDA 483 - Allermed Laboratories, LLC

An FDA inspection of Allermed Laboratories Inc. in San Diego, CA, an allergenic manufacturer, revealed significant deficiencies. Observations included inadequate validation protocols for sterile allergenic extract bulk holding times, insufficient microbial monitoring procedures for cleanroom personnel during aseptic processing, and a deficient media fill process that did not ensure contact with container closures. These issues indicate a lack of control over critical manufacturing processes.