FDA 483 - Sciarra Laboratories, Inc. - August 07, 2023

Sciarra Laboratories, Inc. in Hicksville, NY, a drug manufacturer, was cited for significant deficiencies across multiple quality system areas during an FDA inspection. The firm failed to follow procedures for equipment calibration, conduct proper process validation, adhere to its stability testing program, and adequately document test procedures. Additionally, issues were noted with quality control unit oversight and employee training, indicating a systemic lack of adherence to good manufacturing practices.