Date:
Fri, 08 May 2026 09:35:42 EDT
Content:
The U.S. Food and Drug Administration (FDA) has published a Form 483 detailing inspectional observations for Staska Pharmaceuticals, Inc., an outsourcing facility based in Bennett, Nebraska. The document follows a regulatory inspection of the firm’s operations.
Issued on February 20, 2026, the Form 483 serves as a formal notification to the facility’s management regarding conditions observed by FDA investigators that may constitute violations of the Food, Drug, and Cosmetic Act. Such observations typically relate to manufacturing processes, quality control, or facility maintenance.
As a registered outsourcing facility (FEI: 3017473850), Staska Pharmaceuticals is subject to federal oversight to ensure drug safety and quality. The release of this document to the FDA’s Electronic Reading Room provides transparency concerning the firm’s compliance with current Good Manufacturing Practices (cGMP).
Source: FDA OII FOIA Electronic Reading Room
Link:
http://www.fda.gov/about-fda/fda-commissioner/staska-pharmaceuticals-inc-bennett-ne-483-issued-02202026
Keywords:
FDA, Form 483, Staska Pharmaceuticals, Outsourcing Facility, Bennett Nebraska, Drug Inspection, Regulatory Compliance