FDA 483 - Greer Laboratories, Inc. - December 18, 2024

Greer Laboratories, Inc. in Lenoir, NC, was inspected by the FDA from December 10-18, 2024. The inspection revealed significant deficiencies across multiple areas, including environmental monitoring, production and process controls, equipment maintenance, facility upkeep, and quality control unit procedures. These issues indicate a lack of adherence to established procedures and proper controls for drug product manufacturing and quality assurance.