FDA 483 - Greer Laboratories, Inc. - September 11, 2019

An FDA inspection of Greer Laboratories Inc, an allergenics manufacturer in Lenoir, NC, revealed significant deficiencies in quality control and manufacturing practices. Observations included the release of rejected in-process materials, foreign material contamination in aseptic processing areas, and the use of unreleased bulk extracts. Additionally, the firm's corrective action review process was found to be inadequate, leading to product recalls and rejected lots.