The GMP Letter

The FDA is on track to issue final rules this year on adverse event reporting and cGMPs for device-drug combinations, according to Kristina Lauritsen, a scientific reviewer in the agency’s Office of Combination Products (OCP).

Swiss devicemaker Synthes faces trouble from two sides, with an FDA warning letter posted just days after the company was sued by the families of two patients who died on the operating table during illegal clinical trials.

German devicemaker I.E.M. was hit with a warning letter after FDA investigators found shortcomings with medical device report (MDR) procedures and an array of quality “nonconformities” during a recent inspection of the company’s Stolberg, Germany, facility.

The FDA is stepping up its handling of device and drug cargo thefts, creating a cargo theft response team (CTRT) to assess companies’ action plans after a theft occurs.

The FDA would be required to implement a unique device identification (UDI) system by the end of 2013 if a new Senate bill becomes law.

Endotec was left holding a Form 483 after FDA investigators found shortcomings with the orthopedic devicemaker’s procedures for validating and revalidating medical implants.

Design validation deficiencies at Boehringer Laboratories’ Phoenixville, Pa., plant have landed the company an FDA Form 483.

Infimed, a maker of software and specialized hardware for medical imaging, does not always review all acceptance records and packaging checklists before releasing product for shipment, a Form 483 for the company’s Liverpool, N.Y., plant states.

Starting June 5, devicemakers audited according to internationally harmonized regulatory standards could be spared some annual FDA inspections, under a pilot program described in a final guidance.

Thoratec is voluntarily recalling lots of its HeartMate II Left Ventricular Assist System after receiving multiple reports of product parts falling off during x-rays and surgeries, the FDA says.

Lucero Medical, an Ohio-based maker of vertebral body replacement devices, has been warned for lacking a slew of basic manufacturing procedures and for various 510(k) clearance violations.