FDA 483 - Allchem Lifescience Private Limited - May 17, 2024

Allchem Lifescience Private Limited, a nonsterile intermediate manufacturer in Vadodara, Gujarat, India, received an FDA Form 483 following an inspection conducted from May 14 to May 17, 2024. The inspection revealed several significant observations concerning the firm's adherence to Current Good Manufacturing Practice (CGMP) regulations, particularly 21 CFR. Key issues included the absence of a written program to assess and support the stability characteristics of critical intermediates intended for active pharmaceutical ingredients. Furthermore, the company failed to establish and follow adequate procedures to prevent objectionable microorganisms, specifically by not conducting sufficient microbial testing for process water and final products, lacking a scientific, risk-based rationale for its testing schedule. Lastly, the firm did not follow its own written sanitation procedures, neglecting to implement required pest control services and monitoring in production areas. Allchem Lifescience Private Limited must address these observations by implementing robust corrective and preventive actions to ensure full compliance with FDA regulations and maintain product quality and safety.