483
K.C. Pharmaceuticals, IncFDA 483 - K.C. Pharmaceuticals, Inc - February 13, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
An FDA Form 483 was issued to K.C. Pharmaceuticals, Inc. following an inspection that revealed significant deficiencies across multiple areas of their manufacturing operations. The observations highlight critical issues with aseptic processing validation, quality control unit responsibilities, data integrity, batch record completeness, and contamination prevention, indicating a broad lack of adherence to good manufacturing practices.
Open in Dashboard
ID · 7fb72f69-e3dd-4e53-8a38-ed4c7c7b520f