Simplifying Global Compliance
CDRH’s Office of Compliance is sharpening its focus on international inspections and audits and on labeling, adding two new divisions to meet increasing enforcement demands. Read More
FDA investigators appear to be handling more complex inspections earlier in their careers than in years past, experts say. Read More
The FDA has released a previously announced warning letter to spine implant maker Globus Medical, citing the company for releasing five lots of MicroFuse putty that did not meet its own specification for mechanical testing. Read More
Manufacturers should use a two-step approach to grade nonconforming products — a matrix for determining the initial number, followed by escalations to set a final grade, according to a proposed guidance released last month by the Asian Harmonization Working Party. Read More
Faced with long waits for Brazilian good manufacturing practice certificates, some devicemakers are turning to the courts to speed up product registrations — and seeing their time to market cut in half, an expert says. Read More
CME America failed to investigate the adequacy of its device labeling following three MedWatch reports on administration sets that related to the way a customer was using the device, according to a Form 483 issued to the Golden, Colo., devicemaker. Read More
Kimberly-Clark received a Form 483 after investigators from the FDA’s Dallas district office found it did not retest product lots manufactured on two lines that were involved in earlier findings of contamination. Read More
An FDA investigator handed Chase Medical a Form 483 after the company’s manufacturing assembler admitted she does not always remember to document all in-process tests for the Tripod Heart Stabilizer devices. Read More
San Diego-based Avacen received a nine-citation FDA warning letter for not having established a host of essential GMP procedures. The company makes The Avacen Thermal Exchange System, or TATES. Read More
King Systems has received an FDA warning letter over process validation, in-process testing, complaint handling and storage procedures. Read More
Aptalis, a specification developer for the Flutter mucus clearance device, failed to report a contract manufacturer’s rework of devices to correct issues both this year and in 2012, a recent FDA warning letter says. The company also did not record its justification for that decision. Read More
Medtronic is conducting a voluntary Class I recall of multiple guidewires used to place diagnostics and interventional devices in the coronary and peripheral blood system. Read More
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