The GMP Letter

FDA officials sounded a familiar drumbeat during an Aug. 27 meeting on ways to notify the agency about changes to PMA products, asking devicemakers to submit more complete information upfront to ensure their submissions can be processed quickly.

Medtronic officials will meet Sept. 7 with FDA staff to discuss problems related to faulty SynchroMed II pumps and possible corrective actions, company spokeswoman Donna Marquard told GMP.

Devicemakers must begin registering foreign-manufactured goods that pass through the U.S. but are not sold here, under a new FDA rule.

Ningbo Huahui Medical Instruments was handed an FDA warning letter after telling investigators it lost its design documents for a digital thermometer last year.

The FDA recently got a preview of the comments it can expect on its unique device identification (UDI) draft rule, ranging from whether a change in the identifier would require a new 510(k) or supplemental PMA to questions about date formatting.

How should devicemakers audit virtual companies that are part of their supply chain? The first steps are to figure out who they are and then to tailor a qualification and audit program for them.

Telemetry company ScottCare has corrected all violations found during a site inspection earlier this year, earning an Aug. 13 closeout letter from the FDA’s Cincinnati District Office.

Stryker Orthopaedics is facing a lawsuit alleging damages caused by the company’s titanium alloy Rejuvenate hip system.

Devicemakers in Canada must now pay a fee to renew their establishment licenses annually by April 1, or face cancellation and enforcement actions, according to an updated Health Canada guidance.

An FDA inspector’s determination that a single product at Dynatronics’ Ooltewah, Tenn., manufacturing plant fit Class II requirements triggered a 15-count Form 483 at the conclusion of a May 21-23 inspection, company President Kelwyn Cullimore Jr., told GMP.

Failure to adequately address leaky valve issues led to seven observations in a Form 483 issued to Winter Park, Fla.-based Genicon at the close of a March 26-29 inspection.

A Form 483 filed after an April 30-May 17 inspection of a St. Louis, Mo., Bausch + Lomb plant lists eight observations, including one that was apparently corrected while investigators were on site.

A Tennessee maker of wheelchair components received an FDA warning letter after the agency found problems with the company’s documentation and complaint-handling procedures.

A bevy of documentation shortcomings has led to a warning letter for Compumedics Germany, a maker of Doppler ultrasonic imaging systems.