Hansen Ophthalmic Development Lab, Inc., received a Form 483 for not establishing procedures for corrective and preventive action, and for not maintaining a complete device history record. Source: The GMP…
Panoramic Corp. received a Form 483 for not reporting a correction and removal to the FDA and failing to submit medical device reports (MDRs). Source: The GMP Letter
Inservco Inc. received a Form 483 for not establishing a complaint handling procedure, failing to properly maintain device history records, and other violations. Source: The GMP Letter
White Square Chemical failed to establish a design history file, complete a risk analysis, and committed other violations, according to investigators who handed the company a Form 483. Source: The…
CDRH last week released a list of final and draft guidances it intends to issue in fiscal year 2017. Source: The GMP Letter
The European Commission has published an updated version of harmonized standards that devicemakers and diagnostics makers can reference to ensure their products comply with relevant EU legislation. Source: The GMP…
In the ongoing Theranos saga, the company has now rescinded test results from the past two years for its Edison blood-testing diagnostics. Source: The GMP Letter
B. Braun Medical has agreed to resolve criminal liability allegations by paying $4.8 million in penalties and forfeiting an additional $4 million in restitution for selling contaminated pre-filled saline flush…
The FDA issued a scathing warning letter to Germany-based Qiagen for numerous quality system failures related to its QuantiFeron TB test. Source: The GMP Letter
Having a risk tool to determine what situations require corrective and preventive actions is one strategy devicemakers can use to avoid repeat CAPAs. Source: The GMP Letter