Date:
May 8, 2026
Content:
The U.S. Food and Drug Administration (FDA) has released a Form 483 for SCA Pharmaceuticals LLC following an inspection of its Windsor, Connecticut, facility. The document, which details regulatory observations made by FDA investigators, was officially issued to the firm on March 13, 2026.
As a registered outsourcing facility, SCA Pharmaceuticals operates under specific federal requirements for pharmaceutical compounding. A Form 483 is issued when investigators identify conditions that, in their judgment, may constitute violations of the Food, Drug, and Cosmetic Act or related regulations regarding manufacturing practices and facility maintenance.
The publication of this record in the OII FOIA Electronic Reading Room is part of the FDA’s ongoing effort to provide transparency into the oversight of drug quality and safety. This report allows healthcare providers and the public to review the specific findings identified during the agency’s site inspection.
Source: FDA – SCA Pharmaceuticals LLC Form 483
Link:
http://www.fda.gov/about-fda/fda-commissioner/sca-pharmaceuticals-llc-windsor-ct-483-issued-03132026
Keywords:
FDA, Form 483, SCA Pharmaceuticals, Windsor CT, Outsourcing Facility, 503B, Drug Safety, Inspection Observations