The GMP Letter

Cooper Companies failed to sufficiently warn stockholders about quality problems leading up to its massive recall of Avaira Toric and Sphere lenses, according to a class action lawsuit filed in the U.S. District Court for the Northern District of California.

FDA efforts to speed issuance of devicemaker warning letters and wrap up more investigations are coming up short, if three recent close-out letters are any indication (GMP, May 2011).

A Florida surgical lamp company has received a warning letter over GMP violations and its lack of premarket approval (PMA) for one product line.

The FDA has issued a warning letter to Johnson & Johnson subsidiary Animas for repeated failure to report adverse events with its insulin pumps.

Getting supplier quality under control is crucial if devicemakers wish to avoid the risk of product liability and its accompanying financial hit, industry experts say.

Integra subsidiary Theken Spine was handed a Form 483 for failure to submit 11 of 35 complaints involving products made at its Akron, Ohio, facility.

Addison, Ill.-based Anchor Products received a Form 483 with repeat observations on medical device reporting (MDR) procedures and handling of customer complaints.

Abbott received a Form 483 for “deficiently written or followed” procedures for handling written and oral complaints related to its products.

Omron Healthcare received a Form 483 citing repeat observations for medical device reporting (MDR) procedures, as well as in-house and outsourced management of customer complaints.

Inadequate manufacturing procedures and online claims that overstated the medical benefits of infrared lasers for home use landed two devicemakers in hot water with the FDA.

Rx Air, a Texas-based maker of massive medical air purifiers, was handed an FDA warning letter with eight observations, including lack of established procedures for validating filter tests.

The FDA slapped Johnson & Johnson’s DePuy Orthopaedics with a warning letter citing quality system compliance concerns at its Warsaw, Ind., plant, including lack of proper design validation procedures.