The U.S. Food and Drug Administration (FDA) has given Pfizer's (pfe) Meridian Medical Technologies unit a warning over multiple violations at the Brentwood, Mo.
In the FDA's warning letter this week, the agency excoriated Meridian for what it had found, laying out "significant violations" of the Federal Food, Drug and Cosmetic Act.
The FDA ordered Meridian to review its manufacturing investigations and provide analyses of its processes for spotting quality problems and validating component designs.
"Your own data show that you received hundreds of complaints that your Epipen products failed to operate during life-threatening emergencies, including some situations in which patients subsequently died," the FDA wrote.
Therefore, your firm does not adequately analyze processes to identify existing and potential causes of nonconformities related to product or other quality problems."
- EpiPen maker failed to investigate product flaws associated with patient ...Chicago Tribune
- FDA slams EpiPen maker for doing nothing while hundreds failed, people diedArs Technica
- FDA Accuses EpiPen Maker of Failing to Investigate MalfunctionsNew York Times
- Maker of allergy shot EpiPen neglects hundreds of complaints about defectsThe Straits Times
- FDA warns of serious manufacturing violations in letter to EpiPen ...MarketWatch
- FDA slams Pfizer unit that made EpiPens that failed during fatal emergenciesFiercePharma
- FDA says there have been 'hundreds of complaints' about EpiPen misfires, some ...CNBC
- FDA sends warning letter to maker of EpiPenPittsburgh Post-Gazette
- FDA Warns Of Manufacturing Violations To EpiPen PlantMarkets Insider