An Indian API facility has received a form 483 from the US FDA in the latest setback for troubled drugmaker Ranbaxy.
Following a recent inspection by the US Food and Drug Administration’s (FDA) at the Toansa, Punjab active pharmaceutical ingredient (API) plant, Ranbaxy has confirmed it received the 483 on Saturday but has not revealed how many observations were cited.
In a statement sent by a Ranbaxy spokesperson to in-Pharmatechnologist.com, the company said it currently “assessing the observations, and will respond to the US FDA in accordance with the agency’s procedure to resolve the concerns at the earliest.”
The firm - bought by Daiichi Sankyo in 2008 for $4.5bn (€3.5bn) - has had its fair share of run-ins with the FDA, culminating in a $500m settlement the company paid last year after pleading guilty to charges of manufacturing and distributing adulterated drugs.
The two Indian facilities where the drugs were made - Paonta Sahib and Dewas - were placed under an import alert, leading to a consent decree in 2012 which is still in place.
Furthermore, Ranbaxy received a second import alert in September last year for its Mohali plant, which was subjected to the same consent decree.
The Toansa API plant was not affected by the consent decree, spokesman Chuck Caprariello told this publication in May , but this latest 483 is, however, a blow to remediation efforts the company has undertaken - including the use of independent cGMP auditors at the Paonta Sahib and Dewas sites and the transfer of products to two New Jersey, US sites - to improve quality and ensure safety of future products.
“Ranbaxy continues to improve its systems and processes,” the spokesperson told us today, remaining “fully committed to upholding the highest standards that patients, prescribers, regulators and all other stakeholders expect from the Company.”