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Medical Devices / Inspections and Audits

Pfizer EpiPen Manufacturer Draws Lengthy FDA Inspection Report

Nov. 10, 2017
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A Pfizer company was hit with a lengthy Form 483 from the FDA for 14 nonconformities.

A team of FDA investigators and officials inspected Meridian Medical Technologies’ EpiPen manufacturing plant in Brentwood, Missouri from February through March and found major issues with validating and verifying product designs.

The combination drug/device manufacturer had not established adequate input and output design procedures at the time of the inspection.

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