Failure to document corrective and preventive action (CAPA) activities related to its x-ray equipment landed Deerfied Imaging a Form 483 from the FDA following an inspection of its Minnetonka, Minnesota…
Inadequate procedures for managing corrective and preventive actions and for monitoring and controlling process parameters landed DJ Orthopedics a form 483 following an FDA inspection of its Tijuana, Mexico facility.…
Perahealth didn’t have any design plans for its PeraTrend and PeraServer software used in monitoring patients, and it lacked appropriate documentation for numerous quality system processes, according to a Form…
Failure to file medical device reports with the FDA within the prescribed 30-day period after becoming aware that its glucose meter may have contributed to an injury landed South Korea’s…
The FDA hit UK-based devicemaker Bedfont Scientific with a warning letter for quality failures and the handling of data. Source: The GMP Letter
TEAM-NB, the European Association of Notified Bodies for medical devices, reported that CE certificates spiked by nearly 50 percent last year. Source: The GMP Letter
The Medical Device Innovation Consortium (MDIC) is asking for feedback on its new draft framework for using real-world evidence (RWE) in the development and clearance of in-vitro diagnostics (IVDs). Source:…
A group of U.S. academics and pharmacists has proposed a quality rating system for prescription drugs that would allow bulk buyers to assess the quality of drugs before they make…
The FDA rapped Korean drugmaker Huons for lackluster testing procedures and laboratory controls observed during an inspection. Source: Drug GMP Report
Pharma is pushing back against a slew of proposals by lawmakers to do away with U.S. reliance on foreign drug manufacturing. Source: Drug GMP Report