FDA 483 - Greer Laboratories, Inc. - December 12, 2025

Greer Laboratories, Inc. in Lenoir, NC, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations highlight a lack of adequate procedures and controls to prevent microbiological contamination in aseptic processing areas and issues with the firm's water system. Additionally, the quality control unit failed to follow written procedures for annual product reviews, documentation, and inventory management, indicating systemic problems in maintaining a state of control.