FDAnews Device Daily Bulletin
Medical Devices / Inspections and Audits

Singapore Diagnostics Maker Fails to Establish SOPs for Investigations

May 28, 2019
A A

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.

View today's stories