Cohance Lifesciences Limited – FDA 483, Sep 4, 2026
Cohance Lifesciences Limited, a finished drug product manufacturer in Rangareddy District, India, was cited for significant deficiencies during an FDA inspection. The inspection revealed failures in thoroughly investigating out-of-specification results, inadequate procedures for preventing objectionable microorganisms, and a quality unit that did not fully follow its written responsibilities. Additionally, the firm lacked appropriate controls over computerized systems, indicating serious data integrity concerns.
ID · c0837c7f-9a21-40dc-b5e6-5e651483ef5d
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