Alkem's Enzene Unit Gets 6 USFDA Observations
New Delhi: Alkem Laboratories Limited has announced that the United States Food and Drug Administration (USFDA) has completed a Pre-Approval Inspection (PAI) at the manufacturing facility of its Indian subsidiary, Enzene Biosciences Limited, and issued a Form 483 with six procedural observations, while recording zero observations related to data integrity.
In a regulatory communication, the company informed the Corporate Relationship Department of BSE Limited and the National Stock Exchange of India Limited about the development.
According to the disclosure, the United States Food and Drug Administration completed the Pre-Approval Inspection at Enzene’s manufacturing facility in India. At the conclusion of the inspection, the USFDA issued a Form 483 containing six procedural observations.
The company emphasized that Enzene achieved zero observations related to data integrity, calling it a critical validation of the robustness of Enzene’s quality systems and the reliability of its regulatory filings. Data integrity observations are often considered significant in regulatory inspections, and the absence of such findings was highlighted as a key outcome of the inspection.
Alkem further stated that Enzene is currently in the process of preparing and submitting its response to the USFDA within the stipulated timeline. In parallel, the subsidiary has initiated appropriate corrective and preventive actions (CAPA) to address the procedural observations cited in the Form 483.
Alkem Laboratories Limited, headquartered in India, continues to update exchanges in line with regulatory requirements regarding inspections at its manufacturing facilities and those of its subsidiaries.
