The GMP Letter

FDA inspections reflect a basic business relationship, according to FDA investigator Lori Lawless of the agency’s Baltimore District Office.

X-Ray Support hasn’t registered with the FDA since 2008, making its sales of automatic dental X-ray film processors illegal, a warning letter states.

OraWell USA, a short-lived devicemaker specializing in in vitro diagnostic test kits for HIV detection, has shut down after an FDA warning that its test kits were not cleared and its manufacturing processes violated GMPs.

Devicemaker Rocket Medical failed to maintain adequate design controls and committed other GMP violations, the FDA alleged in a warning letter.

MEAS US, a subsidiary of Measurement Specialties based in Dayton, Ohio, failed to submit a premarket notification to the FDA for three medical devices it modified, a Form 483 states.

Rebuilder Medical has been repeatedly remiss in responding to customer complaints and has not established a management review process during its 10-year history, a Form 483 states.

Applied Diabetes Research’s (ADR) design validation documentation lacks robust risk analysis to ensure its devices conform to defined user needs and intended use, a Form 483 states.

No element of properly executed company compliance work beats corrective and preventive action (CAPA) as a shield from FDA enforcement.

Synthetic organs and medical robotics are among technologies CDRH sees as important regulatory science targets, Director Jeffrey Shuren says in a new report.

The FDA has warned Measurement Specialties for cGMP violations, including inadequate controls for its temperature probes and other devices.

For all the technical complexity of an FDA inspection, the human factor remains key to emerging successfully from an agency visit.

Training can be a fatal burden if not managed properly, device industry experts say.

Diversion of resources from marketing and research to quality and manufacturing figured into a domestic sales slump and a 6 percent drop in earnings at Johnson & Johnson (J&J) in the third quarter from the same period in 2010.

To improve FDA transparency and enforcement data, the agency plans to speed data entry and inspection review and put public information on device regulation into a larger context.

New patterns of non-compliance are spurring the FDA to ponder changing inspections and clinical trial review and to seek more post market studies.