Poor Validation of APIs Result in 483 for Manufacturer

January 30, 2015

A Japanese active pharmaceutical ingredient manufacturer received a Form 483 for poor validation of its manufacturing methods and supplier controls.

During a September inspection of Ishihara Sangyo Kaisha’s Yokkaichi, Japan, facility, the FDA found problems with the facility’s procedures.

Ishihara didn’t show that it properly validates the production process and testing methods used in the manufacturing of APIs, according to the Form 483 with three observations.

The FDA also chided the API manufacturer for lax supplier controls. The written procedure for auditing raw material suppliers doesn’t explain the requirements a supplier must meet in order to be acceptable, the agency said.

Ishihara could not be reached.

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