483 Roundup: Six Firms Flagged for Variety of Violations
The FDA issued Form 483 reports to facilities in Germany, China, Mexico, South Korea, the United Kingdom and the U.S. for a range of nonconformance issues. Source: Drug GMP Report
Warning Letter Roundup: Five Firms Warned for Misbranding, GMPs
The FDA cited issued warnings letter to drugmakers in Japan, Mexico, Australia and to three in the United States for GMP and other deficiencies. Source: Drug GMP Report
FDA to Define GMPs for Outsourcing Facilities
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Source: Drug GMP Report
483 Roundup: FDA Flags 8 Device Firms for Numerous Deficiencies
The FDA cited seven U.S. devicemakers and one in Japan for various noncompliances with regulatory requirements, including inadequate complaint investigations. Source: The GMP Letter
Regulatory Hurdles for Design Changes Stall BSI’s Market Comeback
Boston Scientific is facing regulatory hurdles with its proposed manufacturing process and design changes to bring its transcatheter aortic valve back to the U.S. and EU markets. Source: The GMP…
FDA Warns Oregon Device Firm Over Failing to Respond to Inspection Issues
Biomodeling Solutions drew an FDA warning letter after it failed to provide written responses to nonconformities identified in a Form 483. Source: The GMP Letter
FDA Warns BD Facility in Ongoing Lead Test Probe
The FDA issued a warning letter to Becton Dickinson for distributing adulterated and misbranded devices, among other significant GMP violations, as part of its ongoing investigation of inaccurate blood lead…
Medical Laser Manufacturer Draws Lengthy FDA Warning
Light Age, a New Jersey-based manufacturer of Class II medical lasers, drew an FDA warning letter for 12 different violations flagged during a fall 2017 site inspection. Source: The GMP…
FDA Drafts Guidance on Replacing Reagents for IVD Devices
The FDA issued draft guidance to provide updates on in vitro diagnostics’ replacement reagents. Source: The GMP Letter
IMDRF Updates Device Safety and Performance Assessment Guidelines
The International Medical Device Regulators Forum released new guidance to help global regulators, conformity assessment bodies and industry assess whether a medical device conforms to regulations in each jurisdiction. Source:…
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