The China Food and Drug Administration (CFDA) has issued new guidance on quality control, finished product inspection, and other procedures for medical devices Source: The GMP Letter

The FDA and the Department of Homeland Security have flagged cybersecurity weaknesses in some St. Jude Medical implantable cardiac devices used with the company’s Merlin@home transmitters. Source: The GMP Letter

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

Hong Kong’s Department of Heath issued safety warnings for Boston Scientific Ingevity MRI endocardial pacing leads and Percuflex Urinary Diversion stents, Draeger Medical GmbH Oxylog 3000 and Oxylog 3000plus ventilators,…

United Contact Lens received a warning letter for failing to test finished products and establish written customer complaint procedures. Source: The GMP Letter

Hoggan Scientific LLC was hit with a Form 483 after an inspection revealed a lack of adequate procedures for design control, corrective and preventive actions, complaint evaluation, and other issues.…