The GMP Letter

By pushing inspector training and re-emphasizing a directive that investigators limit their focus to two facility systems, the FDA hopes to do a better job of inspecting device plants and other facilities.

The FDA is moving to streamline enforcement and recalls to avoid delays and increase transparency, FDA officials say.

Device industry executives bent on breaking the law will do so even though HHS has the power to ban individuals convicted of related crimes from participating in federal health programs, according to a Medtronic attorney.

Six years after implantation, more than a quarter of Johnson & Johnson (J&J) metal-on-metal ASR hip systems used to treat British patients had to be replaced, the National Joint Registry of England and Wales said.

Companies should view recent announcements of changes in CDRH leadership as coincidental and not an attempt at reorganization, a former FDA official says.

SRI Surgical failed to adequately validate its sterilization process for making medical devices, a Form 483 states.

Mortara Instrument failed to investigate complaints about melted parts and burning smells in electrocardiographs (ECGs), the FDA says.

Impact Instrumentation didn’t identify or repair flaws, leaving nonconformities in finished or in-process devices, according to a recent Form 483.

A UK devicemaker’s mishandling of complaints and wayward procedures for equipment maintenance, medical device reporting (MDR) and corrective actions drew a warning letter from the FDA.

Finalizing a draft FDA guidance on human factors testing of device design would unfairly punish companies in some instances and be impossible to apply in others, devicemakers say.

The contaminated heparin crisis from years back that affected device- and drugmakers “could still be happening” and the FDA continues to focus some of its limited resources on keeping the fake anticoagulant out of the U.S. drug supply.

The FDA warned German devicemaker Aesculap AG for failing to conduct investigations after receiving multiple consumer complaints.

FDA review of combination products and agency issuance of guidance addressing a swirl of industry uncertainties “lag” behind the swift pace of product development, agency officials say.

FDA inspectors continue to see systemic GMP problems in their overseas inspections, and greater device- and drugmaker oversight of foreign partners — such as on-site compliance officers — may be warranted, FDA officials say.

AngioDynamics failed to report a field correction and the possibility that one of its devices may have figured in a death or serious injury, the FDA said in a May 27 warning letter posted online in late August.

A draft FDA guidance on reprocessing devices is too broad, sets too high a bar and does not go far enough to factor in the circumstances facing companies distributing products globally, devicemakers say in comments on the document.