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.…
Final guidance on reducing cross-contamination from irrigation valves and accessories for flexible gastrointestinal endoscopes adds a new section on testing for backflow prevention. Source: The GMP Letter
CryoSurgery Inc. landed a Form 483 for poorly documented acceptance activities and inadequate procedures for ensuring the quality of received products. Source: The GMP Letter
Manufacturing-related provisions in the recently enacted 21st Century Cures Act establish a program for “breakthough” devices, exempt some categories of medical software from regulation as a medical device, and require…
Aesculap Inc. was cited in a Form 483 for neglecting to file timely medical device reportable (MDR) events and establish timely corrective and preventive actions in response to complaints. Source:…
The FDA has made great strides in conducting international inspections — but still remains detrimentally understaffed, according to the government’s official watchdog, during a time when the agency has begun…