Warning Letter to Device Contractor: Get Your Quality Systems in Order

For the Draft Guidance for Industry Good Importer Practices, click here.

FDA recently issued a warning letter to Connecticut medical device manufacturer Contract Medical Manufacturing, detailing a litany of Quality failures in the areas of documentation, validation, sterile packaging, and control of process parameters. This despite the company’s attempts to rectify previous FDA citations.

To link to the PDF of the warning letter, click here.

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