Greer Laboratories, Inc. – FDA EIR, Aug 27, 2015

An FDA inspection of Greer Laboratories, Inc. in Lenoir, North Carolina, conducted from August 18 to August 27, 2015, revealed significant Good Manufacturing Practice (GMP) non-compliance concerning biological drug products and medical devices. This follow-up inspection to a 2013 Warning Letter highlighted persistent issues.

Key observations from the FDA-483 included a repeat deficiency in retaining representative reserve samples for final product lots. The company implemented critical manufacturing and testing changes, such as in bulk sterility test methods, without prior FDA approval.

Major deficiencies in aseptic processing operations were noted, particularly in contamination prevention. Facility changes to the aseptic filling suite lacked proper qualification, including required smoke studies and media simulations. Aseptic processes were not re-qualified after a trend of sterility failures, with manufacturing resuming prematurely. Assurance against pyrogen/endotoxin introduction during vial inspection was absent, and sterilization tracking for small supplies was inadequate.

Environmental control was critically deficient, evidenced by recurring human hair contamination in aseptic filling areas. This led to product quarantines and rejections, indicating ineffective corrective actions. Investigations into contamination were incomplete, and environmental monitoring, including air monitoring and media qualification, was inadequate. Further, the General Safety Test procedures lacked secure animal housing, posing risks of mix-ups.

Upon the inspection's conclusion, an FDA-483 was issued, detailing these observations. The company’s President and CEO, Richard Russell, committed to implementing necessary corrective actions.