Nagpur: The US Federal Drug Administration (US FDA) found several procedural deficiencies at Lupin Limited’s injectables Unit Two in Nagpur following its inspection on October 17-29, according to the form 483 issued by the drug regulator, reported Moneycontrol.
Lupin, in an exchange filing on October 30 acknowledging the receipt of the form 483, said the inspection pertained to pre-approval of its unit two. As per the form 483 issued by inspector Cynthia Jim, consumer safety officer, the US FDA found the company’s Nagpur facility deficient on five counts. A form 483 is issued by the US drug regulator after an inspection of a facility that has flouted the regulator’s good manufacturing norms, the report published by the website reads.
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Wednesday 12 March 2025
The first observation on the unit was related to the flooring, walls and ceiling of the aseptic processing areas at the facility. An aseptic process in a pharmaceutical plant relates to packaging of thermally sterilised liquid products into sterilised containers under sterile conditions for storage without the need for refrigeration. During the disinfectant effectiveness studies conducted by the US drug inspector on October 20 at the aseptic processing areas, the inspector found that the surface was not polished and was instead texturised.
“Studies have not been conducted to ensure that approved disinfectants are also effective on textured surfaces,” the US FDA said in the form 483.
The second observation by the drug regulator pertained to procedures designed towards preventing microbiological contamination of products made at the facility not being established, written or followed by the staff.
Another observation made by the US FDA inspector suggested that aseptic processing areas at the plant had deficient systems for monitoring environmental conditions, which could contaminate the products undergoing the aseptic process.
One observation in the form 483 highlighted that there is a failure to thoroughly review any discrepancy during the production of a batch of products or the failure of a batch or any of its parts to meet manufacturing standards.
As per US FDA’s regulation the issuance of form 483 does not stop Lupin from continuing to export products from the plant to the US market, however, it will put existing marketing approvals sought by Lupin for products made at the Nagpur plant till the company takes remedial action.“We are committed to addressing the observations at the earliest, and gaining approval for injectable manufacturing for the U.S,” Lupin had said in the exchange filing.
The US FDA gives companies 15 working days to respond to the form 483 with a corrective and preventive action plan.
