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

An FDA inspection of SM Biomed Sdn. Bhd. in Sungai Petani, Malaysia, identified significant deficiencies in the cleanliness and maintenance of restrooms within the production facility. The restrooms were observed to be unsanitary, featuring stagnant water, an unwelcome odor, and lacking essential amenities such as self-locking doors, hot water, and proper drying facilities. These conditions indicate a failure in maintaining adequate sanitation and hygiene standards within the manufacturing environment.