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Devicemakers may need to consult with their legal counsel during an FDA inspection so they know what the agency may legally request, according to inspection expert David Chesney, principal of DL Chesney Consulting.
The FDA issued Rochester, N.Y.-based Fieldtex Products a Form 483 with eight observations for not properly evaluating its suppliers, inadequate handling of nonconforming product and other deficiencies.
The FDA issued a warning letter to Wintech Medipro for marketing its surgical masks without a premarket application or investigational device exemption and for several other lapses observed during an inspection of the company’s Katy, Texas facility.
Devicemakers still using a paper-based quality management system (QMS) should seriously consider adopting an electronic QMS, advised compliance expert Sundeep Agarwal, in a recent FDAnews webinar.
The FDA has issued a warning letter to Nendingen, Germany-based laparoscopy devicemaker Getsch+Hiller Medizintechnik (GH) for unapproved product changes, the lack of a design history file and other lapses observed during a July 2022 inspection.
The FDA has sent neurovascular device company MicroVention a warning letter after the agency was not satisfied with the company’s responses to a Form 483 inspection report which noted problems with validations, correction and preventive actions, and other lapses.
Florida-based medical device specification developer KL Distributing was handed a Form 483 for inadequate purchasing controls, training, medical device reporting (MDR) and other lapses.
San Antonio, Texas-based ErgoMed received a Form 483 after an FDA inspection found a lack of supplier and product controls as well as repeated quality lapses.
Bethesda, Md.-based RightEye, manufacturer of the RightEye Vision System, has received a warning letter from the FDA for marketing its device without a premarket approval application for new indications, failure to maintain written design control procedures and other serious lapses.
Light Age received a Form 483 for multiple deficiencies observed in an inspection of its Somerset, N.J., facility including the lack of a device master record and failing to launch corrective and preventive action (CAPA) procedures.
The SEIU-United Healthcare Workers West union in California has petitioned the FDA to issue corrective recalls for Fresenius 2008K2, 2008T, and 2008T BlueStar hemodialysis machines to protect patients from high ultrafiltration rates and assure accurate conductivity — concentration of dialysis fluid.
Ceragroup Industries (CGI), a Florida manufacturer and distributer of dental porcelain products, recently received a Form 483 citing repeat problems with incomplete corrective and preventive action (CAPA) procedures and equipment lacking proper calibration.