FDA 483 - Greer Laboratories, Inc. - August 27, 2015

An FDA inspection conducted at Greer Laboratories, Inc., an allergenic manufacturer, from August 18-27, 2015, revealed significant non-compliance with pharmaceutical good manufacturing practices. The inspection resulted in eleven observations on Form FDA 483, identifying critical systemic issues.

Key violations included the repeat observation of failing to retain representative reserve samples for each product lot, implementing changes to test media without prior FDA approval, and deficiencies in product release testing, such as inadequate housing for test animals. Major concerns centered on aseptic processing, with the firm failing to properly qualify changes in its aseptic filling suite and demonstrating inadequate requalification after multiple sterility failures. A persistent problem was human hair contamination in aseptic areas, leading to product quarantines and rejections, highlighting ineffective corrective actions. Additionally, the disinfectant effectiveness study was inadequate, environmental and water monitoring media were unqualified, and investigations into contamination events were deficient, often concluding "false positives" without sufficient evidence. Deficiencies were also noted in the media fill program, environmental monitoring, and employee adherence to incident reporting procedures.

Greer Laboratories, Inc. is required to implement comprehensive and effective corrective and preventive actions to address these widespread quality control, aseptic processing, and environmental monitoring failures. These actions are essential to ensure ongoing compliance with FDA regulations for drug manufacturing, thereby safeguarding product quality and patient safety.