FDA 483 Issued in the Calm before the Storm

October 28, 2012
Angie Drakulich

Angie Drakulich was editorial director of Pharmaceutical Technology.

The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy.

The East Coast, including PharmTech’s offices, is largely boarding up and shutting down in preparation for Hurricane Sandy.  But the FDA is still keeping vigilant. Just before the weekend, on Friday, Oct. 26, 2012, FDA released a copy of a Form 483 issued to the New England Compounding Center (NECC), which has been under investigation for violating the Federal Food, Drug, and Cosmetic Act.

“The inspection report for NECC has not been completed and is not being shared at this time,” says the release. FDA is still working with the US Centers for Disease Control and Prevention and Massachusetts partners regarding fungal meningitis outbreak and those patients who received NECC’s compounded preservative-free methylprednisolone acetate (80mg/ml), an injectable steroid, according to the release.

For back story, see the video on PharmTech.com/PharmTechTV regarding the compounding center and its connection to the recent fungal meningitis outbreak.

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