FDA 483 - MP Biomedicals Asia Pacific Pte Ltd - March 21, 2025

MP Biomedicals Asia Pacific Pte Ltd, an IVD manufacturer in Singapore, was cited for inadequate environmental control procedures, including a failure to establish criteria for corrective actions when environmental limits were exceeded, resulting in out-of-specification microbial counts. The inspection also found that the firm lacked approved purchasing data and effective purchase agreements for critical suppliers. These issues indicate a lack of adequate controls over manufacturing environments and supplier management.