Lupin could face FDA regulatory action over Tarapur API facility
India’s Lupin Pharmaceuticals warned Monday it could face regulatory sanctions from the US Food and Drug Administration over its Tarapur active pharmaceutical ingredient (API) manufacturing facility.
“The company has received a communication from the US FDA classifying the inspection conducted at its Tarapur manufacturing (API) facility between September 16 to September 20, 2019 as Official Action Indicated,” Lupin said in a filing to the Bombay Stock Exchange.
According to the FDA’s official definition, an OIA means that “objectional conditions were found and regulatory administrative sanctions by FDA are indicated.”
Lupin said in the filing it did not believe that the inspection classification would have an impact on disruption of supplies or the existing revenues from operations of the facility.
“The company is in the process of sending further updates of its corrective actions to the US FDA and is hopeful of a positive outcome,” Lupin said.
Back in October, the FDA issued a Form 483 listing three observations of violations of current good manufacturing practices (cGMP) at the Tarapur plant.
In the letter, the FDA said Lupin had failed to maintain batch production and control records and not carried out a satisfactory review of unexplained discrepancies “whether or not the batch has already been distributed.”
The FDA also cited failure by workers at the plant “to handle and store cleaned utensils in a manner to prevent contamination.”
Separately in another exchange filing on January 11, Lupin said the FDA had completed a Prior Approval Inspection at its Nagpur oral solid dosage manufacturing facility between January 6 and January 10, closing with 483 observations.
Lupin managing director, Nilesh Gupta said the company was committed to meeting the highest quality standards and to full compliance with current good manufacturing practice regulations at all its manufacturing facilities.
“We will address the observations raised by the agency satisfactorily and will submit our comprehensive response within the stipulated timeline,” he added.
News EU-GMP licence positions MediCane Health as possible cannabis export hubMediCane Health's EU-GMP certification helps to bridge the pharma-cannabis gap
News Panaxia's medical cannabis facility in Malta gains EU-GMP standardThis second facility gives the company a significant power multiplier for export capacity and geographical reach
News China SXT's new lyophilisation facility secures pharmaceutical manufacturing permitThe move, coupled with the plants's passing of a pharmaceutical GMP compliance inspection, will enable company to accelerate the R&D of its novel Advanced TCMPs
News Almac's Charnwood site achieves H&S and environmental certificationThe CDMO plans to roll out the ISO 45001 and ISO 14001 certification throughout multiple sites worldwide
News Europe approves SK Bioscience’s global COVID-19 vaccine plantCDMO's site becomes the first vaccine production facility in South Korea to obtain EU GMP certification, allowing it to ship to Europe
News Pharma importers forced to reorganise supply chains due to Brexit complications, says medicines trade expertEU/UK trade deal fell way short of UK’s initial expectations for medicinal products ahead of negotiations, says Peter Gough at NSF International
News Pharma Explained: What is Quality Assurance?Need clarity on determining your QA from your QbD and your cGMPs? You’re not alone! In our new Pharma Explained series from CPHI, we bring you clear cut definitions from industry experts on a myriad of Pharma Terms, delivered in bitesize video presenta...
News 17th Annual CPHI Pharma Awards winners announcedExcellence in Pharma recognised at virtual ceremony taking place at the CPHI Festival of Pharma.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
Generate high-quality, engaged leads for your business, all year round
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
Your company’s profile boosted at all participating CPHI events
An easy-to-use platform with a detailed dashboard showing your leads and performance