FDA 483 - Micra Biotechnologies, Inc. - August 02, 2024

Micra Biotechnologies, Inc., a contract testing laboratory in River Edge, NJ, was inspected and received a Form 483 with five observations. The inspection revealed significant deficiencies across quality control, employee training, adherence to established laboratory procedures, and overall laboratory controls, indicating a systemic lack of compliance with CGMP requirements. Issues included inadequate documentation, uncalibrated equipment, lack of growth promotion testing, and poor housekeeping and contamination prevention.