The GMP Letter

Organizations that audit device establishments must ensure that their findings document conformity, nonconformity or potential nonconformity with established best practices based on objective evidence, according to a draft standard released by the International Medical Device Regulators Forum (IMDRF).

Devicemakers can begin taking steps to comply with new electronic copy requirements for most types of FDA submissions, thanks to an FDA draft guidance.

St. Jude filed an Oct. 24 Form 8-K with the SEC stating the company had received a Form 483 for observations made during a Sept. 25 to Oct. 17 FDA inspection of its Sylmar, Calif., cardiac rhythm management (CRM) plant.

Quality system violations at Alere’s San Diego, Calif., manufacturing facility have landed the healthcare management company a warning letter.

Strongsville, Ohio, air filtration company HMI Industries landed a 12-observation Form 483 focused on corrective and preventive action (CAPA) shortcomings following an inspection that ran from April 23 through June 4.

The device industry remains largely unprepared for the risk posed to technology by malware and computer viruses, one computer security expert says.

BOSTON — Vision care company Bausch + Lomb found cataract lens development cycles significantly reduced after engineers started examining the way lenses would work in the eye through 3-D computer modeling, a Bausch + Lomb official says.

Lax process and quality control of supplied components helped earn Irving, Texas-based Epimed International an FDA warning letter.

First Medical Source, a Laguna Beach, Calif., company that assembles pain management kits and distributes infusion supplies, received an FDA warning letter related to design control failures and other quality system violations.

CooperSurgical subsidiary Norland received FDA closeout on a warning letter the company received for deviations in complaint handling and good manufacturing practices at its Fort Atkinson, Wis., plant.

Establishing the right kind of verification process and bringing in human factor testing experts early in the development phase are key to successful device design, says industry guru Michael Hoffman.