New Delhi: The US Food and Drug Administration (FDA) has pulled up Lupin for failing to maintain records of batches of medicines manufactured and their sales at the company’s Tarapur plant. The regulator also pointed out that batch production and control records at the plant do not include complete information relating to production and control of each batch.
The observations were part of a Form 483 issued after an inspection of the facility during 16-20 September. The US FDA had made three observations for the facility in the Form 483 then, which Lupin had announced on 23 September.
The regulator made the Form 483 public on Wednesday. A Form 483 is issued when the regulator observes violations of current good manufacturing practices (cGMP) at a plant it is inspecting.
The US FDA also observed that the officials at the plant stored cleaned, non-dedicated utensiIs like scoops, measuring vessels and solvent weighing containers together with unclean drums, risking contamination of drug products manufactured at the plant.
On September 23, Lupin informed exchanges that it has received three observations for the Tarapur plant, which manufactures active pharmaceutical ingredients. However, the company had not provided the details of the nature of the observations.
“The Company is confident of addressing them satisfactorily," Lupin had said.
Lupin has been struggling with regulatory issues at its US FDA-approved plants for two years. In November 2017, the company had received a warning letter for its Goa and Pithampur plants, which remains in place. To add to its woes, Lupin received another warning letter last month, this time for its API-manufacturing plant at Mandideep.
The US FDA in its warning letter for the Mandideep plant had said similar violations of cGMP norms at the three plants indicated a company-wide problem, which Lupin needed to rectify.
Last week, the company appointed Johnny Mikell as its new global head of quality.
The Mumbai-based company is the world’s eighth largest generics pharmaceutical company by revenues, and the third largest pharmaceutical player in the US by prescriptions.