FDA Issues Warning Letter to Sato PharmaceuticalBy
The US Food and Drug Administration (FDA) has posted a Warning Letter to Sato Pharmaceutical, a Tokyo-headquartered manufacturer of over-the-counter drugs, following an inspection of the company’s drug manufacturing facility in Tokyo for violations of current good manufacturing practice regulations for finished pharmaceuticals. The inspection occurred from February 8 to 12, 2016.
The FDA noted that Sato failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas and failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes.
Source: Food and Drug Administration