The United States Food and Drug Administration (US FDA) released a detailed report today (April 10) on the ten procedural observations it had made on Alkem Laboratories' Baddi unit last month.
The US FDA conducted an inspection of the manufacturing facility from March 19 to 27. The inspection covered both compliance with Good Manufacturing Practices (GMP—guidelines issues by the agency) and a Pre-Approval Inspection.
The observations include cleanliness and procedural errors, including "failure to thoroughly review any unexplained discrepancy" and "control procedures are not established", according to the US FDA report.
"This Inspection is part of the routine business operations and the Company shall submit to US FDA within the stipulated timeline, a detailed response to close out the said observations," Alkem had said in an exchange filing at the conclusion of the inspection.
The regulator also found that quality control unit responsibilities and procedures were not in writing, nor were they fully followed in the plant.
On cleanliness, it observed that the plant lacked separate or defined areas to prevent contamination or mix ups and that equipment and utensils were not cleaned, maintained, and sanitised at the time of the inspection.
The report also stated that plant has not established appropriate controls to govern computer acquired data. Handling and storage of drug product containers did not ensure that they were free from contamination, it added.
The US FSA team found that control procedures had not been established to monitor performance or validate the output of the production line. Lab controls in the plant also did not include establishment of scientifically and sound, appropriate specifications, the report noted. Reserve samples from representative samples or batch lots were not examined visually, it added.
The US FDA issues a Form 483 to a firm's management at the conclusion of an inspection when investigators observe conditions that in their judgment may constitute violations of the Food, Drug and Cosmetic (FD&C) Act and related Acts. Observations are made when, in the investigator’s judgement, the conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions where it may be adulterated or rendered injurious to health.
Also read: Indian pharmaceutical market registers 9.5% growth in March
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