The GMP Letter

The FDA is considering requiring quality agreements between medical product manufacturers and their suppliers as part of its push for tighter control of the supply chain, an FDA consumer safety officer says.

As two investigations into Boston Scientifics’ Cardiac Rhythm Management (CRM) division come to a close, the devicemaker is preparing to defend itself against safety allegations from the FDA.

Gyn Disposables violated GMP controls on design, material and production for the company’s intrauterine device (IUD) insertion and endometrial biopsy kits, an April 5-12 FDA inspection of the devicemaker’s Memphis, Tenn., facility found.

Oldsmar, Fla.-based Gulf Medical Fiberoptics violated device quality system (QS) regulations with flawed supply chain quality assurance and inadequate corrective and preventive action (CAPA) procedures, FDA investigators found during a recent inspection.

Beckman Coulter diagnostic analyzers, reagents, calibrators and controls violate cGMP requirements, the FDA says. Inspectors found the deviations at the devicemaker’s Brea, Calif., facility between March 1 and May 12, the agency said in an Aug. 9 warning letter.

The FDA has warned Coral Springs, Fla.-based Spinetronics for cGMP failures, including its lack of procedures to ensure purchased products and services conform to code.

King International’s ShoulderFlex Massager can kill or strangle users, the FDA says, warning consumers and practitioners away from the device.

FDA inspectors recently observed lax corrective and preventive action (CAPA) procedures and complaint systems management at DePuy Orthopedics as the Johnson & Johnson subsidiary faces federal scrutiny of its hip replacement systems.

The FDA has handed Steris Corporation two Form 483s related to its System 1 and System 1E liquid chemical sterilant processing systems, which have already received regulatory scrutiny.

Beckman Coulter filed incomplete medical device reports (MDRs) on its reagents and analyzers — and in numerous cases failed to file MDRs at all — despite physician concerns that its devices were producing erroneous results, according to an FDA Form 483.

CDRH has made public its standard operating procedure (SOP) for developing guidance documents, which it says could reduce the time to develop a guidance from multiple years to as little as six months.

An FDA nanotechnology guidance is useless because it is vague, provides no new information and doesn’t pay adequate attention to international standards companies already use, devicemakers say in comments on the draft.

The device industry in late July slammed a draft FDA guidance on 510(k) device modification, saying its requirements involve unnecessary, burdensome recordkeeping for companies making manufacturing changes.

Fears of hackers compromising implantable devices are unfounded, the industry says.