Cohance Lifesciences announced that its formulation (FDF) plant in Shamshabad, Telangana, underwent an inspection by the United States Food and Drug Administration (USFDA) from August 27 to September 4, 2026. The inspection concluded with the issuance of a Form FDA 483, detailing four observations. The company is actively implementing corrective and preventive actions (CAPA) and will submit its response within the stipulated timeline, affirming its commitment to quality and regulatory compliance.
USFDA Inspection at Shamshabad Facility
Cohance Lifesciences Limited has disclosed the outcome of an inspection conducted by the United States Food and Drug Administration (USFDA) at its formulation (FDF) manufacturing plant. The inspection took place at the facility located in Shamshabad, Telangana, spanning from August 27, 2026, to September 4, 2026.
Inspection Findings and Corrective Actions
Upon conclusion of the inspection, the USFDA issued a Form FDA 483, which outlined four observations. In response, Cohance Lifesciences has already initiated the process of implementing appropriate corrective and preventive actions (CAPA). The company stated that it will submit its comprehensive response to the observations within the legally stipulated timeline.
Commitment to Quality and Compliance
Cohance Lifesciences reiterated its dedication to maintaining high standards of quality and ensuring ongoing regulatory compliance across all its operations. This proactive approach underscores the company’s commitment to addressing any identified issues and maintaining the integrity of its manufacturing processes.
Source: BSE
