The GMP Letter

The FDA is developing new methods and laboratory expertise to aid reviewers in identifying potential vulnerabilities and assessing risk mitigation measures for medical software.

Covidien’s January recall of a surgical staple product hasn’t ended the company’s troubles, as an FDA warning letter questioning Covidien’s handling of safety concerns makes clear.

Siemens Healthcare Diagnostics has come under FDA scrutiny after an inspection at its Tarrytown, N.Y., plant found the company was marketing a diagnostic test that had never been officially approved.

A class action lawsuit that used FDA Form 483 inspection reports to demonstrate that KV Pharmaceutical made false or misleading statements regarding its regulatory compliance can proceed even though inspection reports are not final agency determinations, an appeals court ruled.

Backlash over chromium contamination in some drug capsules may hit devices, as China’s State Food and Drug Administration (SFDA) proposes to draw up a “blacklist” of executives who oversee companies in China found to produce substandard or counterfeit medical products.

Johnson & Johnson (J&J) subsidiary McNeil received an FDA warning letter on a variety of violations related to personal lubricants, feminine hygiene products and other consumer goods.

Last year’s court ruling that sent four former Synthes executives to prison for clinical trial deaths represents an expansion of case law and a warning to other devicemakers, a legal expert says.

Medtronic Spine received a Form 483 for various process control deviations at the conclusion of a Nov. 28, 2011, – Dec. 5, 2011, inspection at its Sunnyvale, Calif., plant.

An FDA inspection of Salt Lake City-based BioMeridian International resulted in 16 observations, most relating to missing procedures or documentation.

The FDA’s Cincinnati District Office issued a Form 483 to a maker of electroencephalogram application caps and related supplies due to missing validation and control procedures at its Eaton, Ohio, plant.

The FDA conducted 949 bioresearch monitoring inspections in fiscal 2011 — 220 fewer inspections than in the previous year — with the decrease spread among all relevant agency centers as they move to a more risk-based approach.