You've been warned: This week in FDA med tech warning letters

The FDA posted warning letters against a number of med tech companies this week, including makers of catheters, IV equipment, surgical tools and contact lenses. Here's a roundup:

  • Alpha Medical Instruments: Regulators cited this California company because it lacks PMA approval for its angiographic balloon catheters and electrophysiology catheters. They also faulted it for improperly claiming its devices are made in the U.S.A. Additionally, the FDA took issue with a number of quality system violations. Alpha's June 24, 2013 warning letter is based on an inspection of its Mission Viejo, CA, operations from Dec. 19, 2012 through Jan. 11, 2013.
  • Biomedix: The FDA accuses the maker of the Select-3 Intravenous Administration Set of a number of quality system violations, such as lacking procedures to make sure the device is produced according to design requirements. They also cite the Bloomington, IN, company for not establishing processes to correct problems. And then there's this: Regulators say the company didn't prove its sterilization process is either successful or safe. On top of that, the June 14, 2013 warning letter cites Biomedix for not gaining proper approvals for changes it made to the Select-3 before selling it. The FDA action is based on an inspection of the company from Feb. 5-March 4, 2013.
  • SpineNet: Regulators inspected this Winter Park, FL, company from Jan. 29-Feb 1, 2013. Their May 31, 2013 warning letter accuses SpineNet of various quality system, medical device reporting and listing violations involving its anterior cervical cage system, the Apollon and Vane Pedicle Screw Systems and its bone marrow aspiration needle kit. Among regulators' concerns: they allege the company lacks a system to allow for timely reporting of product problems. They also say the bone marrow aspiration needle kit is without proper clearance or approval.
  • Aurora Optics Company: The FDA inspected the College Point, NY, operations of this maker of soft contact lenses on Oct. 11-16, 2012. Their April 18, 2013 warning letter cites the company for various medical device reporting violations, such as not having a procedure to handle and evaluate complaints for its Hollow and Aurora brand contact lenses. Regulators also criticized the company for not having detailed enough instructions for use.

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