A manufacturing defect in MicroPort Orthopedics’ Biolox Forte 36 mm Alumina ceramic heads may cause surgical complications, according to Australia’s Therapeutic Goods Administration. Source: The GMP Letter

The FDA sent Canada-based Savaria Concord Lifts a warning letter citing twelve violations regarding corrective and preventive actions (CAPAs), complaint evaluations, software validation, and other areas. Source: The GMP Letter

The FDA flagged numerous compliance issues following an inspection of Cardiac Science’s Deerfield, Wis., facility. Source: The GMP Letter

Combining various risk metrics into a single number can help manufacturers rank suppliers according to risk and identify those that might need to be dropped. Source: The GMP Letter

Becton Dickinson Caribe received a Form 483 for its corrective and preventive action, device acceptance, and process validation procedures. Source: The GMP Letter

Best Medical Canada landed a Form 483 for not establishing adequate complaint procedures or ensuring that its devices conformed to specifications. Source: The GMP Letter

The FDA has reclassified antigen-based rapid influenza virus antigen detection test systems (RIDTs) from Class I to Class II devices and has introduced special controls aimed at improving the quality…

FDA inspectors hit Covidien with a Form 483 for inadequate complaint evaluation and process control procedures, as well as failure to ensure appropriate design and installation of manufacturing equipment. Source:…

Nomax received a warning letter for failing to evaluate complaints, document corrective and preventive actions, and committing other violations. Source: The GMP Letter

Zimmer Biomet’s Warsaw, Ind., medical device facility was hit with a massive, 58-page Form 483 arising from an inspection carried out from September to November of 2016. Source: The GMP…