FDA 483 - SM Biomed Sdn. Bhd. - March 07, 2013

An FDA inspection of ST.T Biomed Sdn. Bhd. was conducted from March 4 to March 7, 2013, at its pharmaceutical manufacturing facility in 08000 Sungai Petani, Kedah Darul Aman, Malaysia. The inspection resulted in the issuance of an FDA Form 483, detailing a significant observation related to facility maintenance and sanitation. The primary issue identified was the unhygienic condition of restrooms located within the production facility. Inspectors observed stagnant water on the floor, a lack of self-locking doors, and an unwelcome odor. Furthermore, these essential facilities were not equipped with air dryers or single-service towels, and hot water was unavailable. These findings indicate a potential deviation from the cleanliness and sanitation standards expected under Current Good Manufacturing Practices (CGMP) for pharmaceutical environments, which are crucial for preventing contamination and ensuring product quality. As a result of this FDA Form 483, ST.T Biomed Sdn. Bhd. is required to provide a formal response to the FDA. This response should outline comprehensive corrective actions to address the identified deficiencies, particularly concerning the cleanliness, maintenance, and proper equipping of its production facility restrooms. The company must demonstrate its commitment to rectifying these issues to ensure compliance with regulatory expectations for a pharmaceutical manufacturer.