The GMP Letter

A recent FDA draft guidance on distinguishing product recalls from product enhancements has met strong industry resistance, with many commenters asking the agency to withdraw the guidance and try again.

CINCINNATI — The FDA is considering a more flexible interpretation of its quality system regulations to help devicemakers more effectively respond to post-inspection Form 483s and reverse a nearly decade-long trend of little improvement in enforcement actions, CDRH Office of Compliance Director Steve Silverman said at MedCon 2013.

The FDA’s failure to release a final rule on unique device identification by last month’s deadline could delay efforts by other branches of government to put UDIs into use, according to lawmakers.

A new warning letter to Hospira’s Lake Forest, Ill., facility cites 12 findings related to its infusion pump manufacturing.

The FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds.

Medtronic Neuromodulation received a Form 483 after it continued to distribute models of SC catheters that didn’t conform to an updated design, intended to fix a field issue.

Ithaca, N.Y.-based Transonic received an FDA Form 483 after an inspection revealed several CAPA shortfalls.

The complaint procedure at Cleveland-based Gebauer did not define how to handle investigations when the product at issue is not returned, according to a recent Form 483.

Devicemakers may need to brush up on their acceptance activities, as these are among the most frequently cited issues in warning letters for 2012 and 2013, says Dan O’Leary, partner with Ombu Enterprises.

Manufacturers should prepare for the possibility of extreme weather events by establishing a “safety stock” based on a site and product contingency plan, along with a disaster recovery program that defines inventory and back-up equipment, Sanofi advises in comments to the FDA.

CooperSurgical, doing business as Lone Star Medical Products, failed to use its MDR determination form for a series of four complaints about vaginal lacerations that required suturing, a recent warning letter reveals.

Weber Medical GmbH, a German manufacturer of laser therapy equipment, failed to follow its procedure requiring suppliers to have a quality management system in place, according to an FDA warning letter.

Electromedical Products International failed to reevaluate its supplier, per its written procedure, after finding high numbers of nonconformances in three lots of contract-manufactured devices, according to a recent FDA warning letter.

Riverpoint Medical failed to document and follow commitments for some of its corrective and preventive actions (CAPAs), resulting in a May 1 warning letter from the FDA.

The FDA has warned Biocompatibles, a maker of radioactive brachytherapy needle sets, for process validation failures and for not initiating corrective actions after complaints of injection errors.