Two CRLs later, Illinois-based CDMO hit with FDA warning letter over 'spore-forming' bacteria and fungi
Dupo, IL-based contract manufacturer Sterling Pharmaceuticals has had a long, tough year.
Last September, partner Verrica Pharmaceuticals’ NDA for a potential skin disease treatment was hit with a second CRL, with the company pinning the problems on Sterling. Eight months later, Verrica was hit with a third CRL due to further issues at Sterling, following a February reinspection by FDA of the Sterling site.
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