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Singapore Diagnostics Maker Fails to Establish SOPs for Investigations

May 24, 2019

Diagnostics maker MP Biomedicals Asia Pacific neglected to put in place standard operating procedures for investigations, landing it in hot water with the FDA following a Dec. 10-12, 2018 inspection of its Singapore facility.

Recurring events such as dirty marks on nitrocellulose strips were identified, but a protocol defining when investigations should be conducted had not been developed, the Form 483 said.

Complaint records at the Singapore-based firm were found to be deficient in that they didn’t include findings and trend analyses, and CAPA procedures were not initiated.

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