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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
The FDA is advising healthcare professionals to strictly follow the instructions for use for cranial perforators with automatic clutch mechanisms following reports of more than 200 injuries related to their use. Read More
Failure to inform the FDA about a medical device correction or removal has earned Merge Healthcare, a developer of medical image handling and processing, interoperability and clinical systems, a warning letter. Word of the letter came just as IBM closed its deal to buy Merge, which will become part of IBM’s new Watson Health business for $1 billion. Read More
Theranos, a hot startup that recently received media scrutiny regarding its testing system, has been hit with two 483s, one of which takes the company to task for shipping an uncleared 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 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
Hospira’s Lake Forest, Ill., manufacturing facility received an FDA Form 483 for numerous 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
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
Devicemaker Cepheid received an FDA Form 483 for design validation failures and inadequate medical device reporting procedures following a June 1 to 16 inspection at its Sunnyvale, Calif., manufacturing plant. 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
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