FDA 483 - SATYADEEPTHA PHARMACEUTICALS LIMITED - January 11, 2018

An FDA inspection of Satya Deeptha Pharmaceuticals Limited in Humnabad, India, revealed numerous deficiencies across its manufacturing and quality systems. The firm failed to maintain adequate batch production and control records, properly validate processes and test methods, and ensure the integrity of electronic laboratory data. Significant issues were also noted in supplier qualification, equipment cleaning validation, and the thoroughness of deviation investigations, indicating a broad lack of adherence to cGMP regulations.