We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
It can help to learn more about an FDA inspection team ahead of time, said inspection expert David Chesney, principal of DL Chesney Consulting, in a recent WCG FDAnews webinar.
The FDA handed cardiac device manufacturer Atrium Medical a Form 483 after a July-August 2022 inspection of its facility in Merrimack, N.H., found inadequate design and process controls among other lapses described as repeated systemic deficiencies.
Devicemakers should err on the side of caution and open a Corrective and Preventive Action (CAPA) investigation even if they are unsure it’s required, said Judith Meritz, life sciences regulatory consultant with Meritz & Muenz, in a recent WCG FDAnews webinar.
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.