The US regulator detailed its concerns in a letter this week, explaining that procedures introduced by Sato are not sufficient to address problems observed by inspectors who visited the facility in Hachioji, Tokyo last February.
For example, the FDA said while the new procedures set out how staff employed in the plant’s sterile production areas should be tested for micoorganisms, they do not make clear what should be done when results are out of spec.
The US agency also voiced concerns that Sato had released products processed prior to renovating a restricted access barrier system (RABS) on an aseptic manufacturing line that was deemed to be deficient during the original inspection.
The FDA said: “Your response is deficient in that it does not address your release of products currently on the U.S. market using the original open RABS design.”
It called on Sato to provide a risk assessment describing process failure modes, full sterility history, and all actions taken to evaluate productsmade on the open RABS unit.
Sato makes over-the-counter drugs which are sold in Asia, Europe and North America.
According to the firm’s website the Hachioji facility’s production systems are compliant with Good Manufacturing Practices (GMP) in the US, Australia, the EU, and Canada.