The GMP Letter

The FDA is planning to reorganize its Office of Regulatory Affairs (ORA), including creating new offices and reorganizing others, as it takes steps to dissolve cumbersome domestic and international distinctions and keep pace with increasingly global operations.

Gut instincts can play a crucial role in telling devicemakers what they need to know in selecting suppliers, an FDA official says.

In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the lifecycle integrity of products.

The FDA plans to issue clarifying guidance to address confusion among devicemakers about what exactly constitutes an enhancement and what qualifies as a recall, a CDRH official says.

Contact lens manufacturers should tie risk assessments to the shelf life of their products to ensure they don’t deteriorate during storage and are safe and effective when used, a revised International Organization for Standardization (ISO) standard advises.

An FDA warning letter issued to Hospira’s infusion pump plant in Costa Rica may be emblematic of broader companywide manufacturing issues, analysts say.

Reports of two serious injuries, including one fatality, prompted Stryker to issue a Class I recall of the Neptune Waste Management System.

BALTIMORE — Aware that issuances and closures of devicemaker warning letters are lagging, CDRH recently uncovered 60 “confusing factors” impeding its performance and efforts are underway to weed them out, center officials say.

FDA enforcement of unique device identifier (UDI) requirements will likely be delayed to allow for ample implementation time, but unwritten mandates in the draft rule with the potential to snarl inspections require prompt attention, compliance experts and former agency officials say.

Devicemakers seeking ISO 13485 certification can expect longer initial audits of their quality management systems (QMS), thanks to a new mandatory document by the International Accreditation Forum (IAF).

St. Jude Medical’s Penang, Malaysia, plant received a seven-observation Form 483 at the conclusion of a May 2011 CDRH inspection.

American Optisurgical, an ophthalmic device company based in Lake Forest, Calif., received a 13-observation Form 483 after an inspection by Irvine, Calif., CDRH staff that stretched from Jan. 30 to Feb. 23.

Riverside, Calif.-based Pacific Consolidated Industries (PCI) received a nine-count Form 483 after inspectors from the Irvine, Calif., CDRH office found deviations in the company’s complaint and adverse event handling activities.

Reports of a 24 percent increase in recalls caused by medtech software may not accurately reflect the scope of the problem or what it means for suppliers, an expert says.

The FDA has warned BioMerieux for several violations related to rework procedures and corrective and preventive actions (CAPA) for its microbial detection systems.