Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3013736415.
Observations3
Issue DateMarch 13, 2026
Status1 Related Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections3
Establishment Details
Firm
SCA Pharmaceuticals, LLC
Location
Windsor, Connecticut, United States
FEI Number
3013736415
Establishment Type
Outsourcing Facility
Product Type
Drugs
Issue Date
March 13, 2026
Country
United States
Inspection History, 2019 to 2024
VAI2
OAI1
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.