FDA finds pharmacy failed to maintain ‘clean rooms’ as cases rise in meningitis outbreak



images-1Health officials and doctors have tracked down most of the 14,000 people potentially at risk for fungal meningitis, blamed for the deaths of 25 people and sickening 338 — but the outbreak is still posing challenges.

In addition to the new numbers released by the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration released Friday a copy of the Form 483, which was issued to the New England Compounding Center (NECC).

The agency issues a Form 483 at the end of an inspection when investigators believe they may have observed conditions or practices in violation of the Federal Food, Drug, and Cosmetic Act, or other related regulations.

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