SUNNY PHARMTECH INC. – FDA 483, Apr 4, 2026

Sunny Pharmtech Inc. received a severe FDA Form 483 citing widespread deficiencies across its manufacturing and quality control operations, particularly impacting sterile drug products exported to the U.S. market. Key issues include inadequate aseptic process validation, falsification of laboratory data, poor data integrity practices, and a dysfunctional Quality Unit. These failures raise significant concerns about the safety, purity, and quality of the firm's drug products.