Device Makers Issued Warning Letters From FDA

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Several medical device makers have been issued warning letters by the U.S. Food and Drug Administration:

• RespCare and InnoMed Technologies, which both manufacture continuous positive airway pressure (CPAP) interface devices for treating respiratory problems and sleep apnea, have been cited for failing to ensure that corrective and preventive action procedures do not negatively affect finished devices. During an inspection of the companies’ Coconut Creek, Fla., plants, an investigator found that hybrid CPAP products had valves misassembled at their contract manufacturer in Taiwan.

The two companies operate at the same address and have the same management.

See the warning letter at www.fda.gov/foi/warning_letters/s7058c.htm.

• California firm Nebion was forced to close last year after it received a warning letter from the FDA. The company believed that the device didn’t fall under FDA regulations because it was only used for testing, it said. The company also said its experimental HLX-8 magnetic resonance device was being used on individuals who knew the testing was part of development and were fully aware that the product was not FDA approved. Nebion recalled eight HLX8 devices on July 2, 2008, and notified their customers to immediately halt device use. The recall came shortly after an FDA inspection of the company revealed that Nebion had not obtained FDA marketing approval or clearance for the HLX8 device. The device treats cancer, migraines, arthritis, and ruptured discs.

See the warning letter at www.fda.gov/foi/warning_letters/s7075c.htm

• The FDA is requiring that Haemonetics certify its manufacturing and qualify its assurance systems. The move was prompted by an inspection of the Massachusetts-based company’s thromboelastograph devices and accessories.

The agency has given the firm until June 1 to complete its initial certification. In addition, the company’s CEO must acknowledge receipt of the consultant’s report and affirm that Haemonetics has initiated or completed all corrections. The agency is calling for subsequent certifications by June 1, 2010.

In the warning letter, the FDA cites the blood-processing technology company for failure to establish and maintain procedures for implementing corrective and preventive action.

See the warning letter at: www.fda.gov/foi/warning_letters/s7060c.htm.

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