Alkem Labs Faces USFDA Observations At Enzene Biosciences Facility

Alkem Laboratories Limited has disclosed that the USFDA recently conducted an inspection at the manufacturing facility of Enzene Biosciences, its wholly owned subsidiary. Following the inspection, the USFDA issued Form 483 containing six procedural observations.  

Form 483 is issued when inspectors identify conditions that may violate the Food Drug and Cosmetic Act. Alkem clarified that the observations are procedural in nature and do not relate to data integrity or product quality. The company assured stakeholders that it is committed to addressing all concerns raised by the regulator within the stipulated timelines.  

Key highlights from the announcement include  

• USFDA inspected Enzene Biosciences’ manufacturing facility  
• Form 483 issued with six procedural observations  
• Observations are not related to product quality or data integrity  
• Alkem committed to corrective actions and compliance measures  
• Company assures stakeholders of timely resolution and transparency  

Industry experts note that while Form 483 observations are common in pharmaceutical inspections, timely remediation is crucial to avoid further regulatory action. Alkem’s proactive stance reflects its commitment to maintaining global compliance standards and ensuring uninterrupted supply of its products.  

Sources: Reuters, USFDA Inspection Reports, Alkem Laboratories Regulatory Filing