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The FDA handed Noven Pharmaceuticals a 13-item Form 483 for lapses in batch reviews and testing, stability and process controls and complaint handling. Read More
Del Medical, a radiography and medical imaging devicemaker, has been hit with a 483 that includes three repeat observations cited during previous inspections — specifically, failure to report complaints. Read More
FDA investigators conducting quality system inspections are becoming a more common sight at international facilities, according to new numbers unveiled last week by the agency’s device center. Read More
Round Rock, Texas-based Cardiac Designs received an Aug. 7 warning letter for design validation failures, inadequate complaint handling procedures and CAPA failures for its mobile heart monitoring device. Read More
Quality system lapses — including process validation snafus — failure to address nonconforming products and not evaluating suppliers efficiently are some of the reasons contract device manufacturer Troy Innovative Instruments has fallen afoul of the FDA. Read More
The FDA handed Noven Pharmaceuticals a 13-item Form 483 for lapses in batch reviews and testing, stability and process controls and complaint handling. Read More
The FDA has hit Albany, N.Y.-based CMP Industries, a manufacturer of resins for dentures, with a warning letter for not adequately investigating “rust-like specks” found in one of its products, among other violations. Read More
FDA handed devicemaker Synovis a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More
Hospira’s Lake Forest, Ill., manufacturing facility received an FDA Form 483 for quality system deviations related to its infusion pumps, including inadequate design validation, inadequate design change procedures and inadequate corrective and preventive action procedures. Read More
The UK’s Medicines and Healthcare products Regulatory Agency, along with other European health regulators, have suspended CE certification for all products made by Brazilian implant maker Silimed after particle contamination was discovered during a facility inspection. Read More
The FDA handed Italian devicemaker Cane S.p.A. a warning letter for not including a software validation procedure in a Form 483 response, after the agency determined that production of the Crono S-PID-50 infusion pump did not comply with current good manufacturing practices. Read More
Speaking at AdvaMed 2015, FDA Associate Director for International Affairs Kim Trautman renewed her call for participants in the International Medical Device Regulator Forum’s single audit pilot program, saying devicemakers have proven reluctant to join. Read More