FDA 483 - SM Biomed Sdn Bhd - March 23, 2018

An FDA inspection of SM Biomed Sdn. Bhd., a pharmaceutical manufacturing facility located in 08000 Sungai Petanl, Kedah, Malaysia, was conducted from March 19 to March 23, 2018. During this inspection, a critical observation was documented related to equipment validation. The facility lacked documented evidence demonstrating that the printer, which is essential for imprinting vital information such as batch numbers, manufacturing and expiry dates, and gross/tare/net weights onto pre-printed Active Pharmaceutical Ingredient (API) templates, had been adequately validated. A significant discrepancy was noted where the printer identified in the company's validation protocol and report (Canon Laser Printer SMB/QAD/PRI/003) was not the same unit (SMB-PTR-11) observed in actual use during the inspection. This situation suggests a failure to maintain control over critical production equipment and ensures its fitness for intended use. This finding, issued on an FDA Form 483, signifies a potential deviation from current Good Manufacturing Practices (cGMP) for pharmaceutical manufacturing. SM Biomed Sdn. Bhd. is expected to address this observation promptly by submitting a comprehensive response outlining corrective and preventive actions to ensure all critical equipment is properly validated, accurately identified, and consistently used according to regulatory requirements to prevent recurrence.