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Viramed Biotech, a German manufacturer of in vitro diagnostics, received a one-observation Form 483 related to an issue with its quality control procedure. Read More
The FDA has warned a Mississippi compounder for not disinfecting its clean room equipment and for other serious manufacturing violations, capping a busy year for the agency’s compounding pharmacy enforcement. Read More
Ensuring that product components and supplies are of top quality and delivered on time is key to running a successful business, and supplier qualification surveys need to be sufficiently broad to ensure a good result, an industry expert says. Read More
An FDA decision to allow multiple entities to issue unique device identifiers could backfire and actually impede the uptake of UDI, medical device and healthcare industry experts warn. Read More
The FDA has warned Miami-based Trucare Biomedix-USA over slips on supplier audits, purchasing controls and other good manufacturing practices. Read More
Inadequate CAPA procedures led all other causes for Form 483s issued to devicemakers in fiscal 2014, while purchasing control issues jumped from sixth place to third in the FDA’s annual ranking of inspection observations. Read More
Using QSIT for internal audits could put devicemakers in a much stronger position when FDA investigators coming knocking on the door, compliance experts agree. Read More
San Antonio, Texas, contract manufacturer Voss Plastics received a 10-citation warning letter for serious lapses in good manufacturing practices and lack of written procedures for adverse event reporting. Read More