The US Food and Drug Administration (FDA) released details of an inspection of Torrent Pharmaceuticals’ Indrad, India, facility, which resulted in a 17-page document, four observations and a Form 483.
The FDA Form 483, made public last week, refers to issues with finished drug products and active pharmaceutical ingredients (APIs) produced at the site.
The agency’s inspections took place from April 8 to 16 April 2019. However, the report noted that the FDA’s investigation had accrued data from January 2017 to March 2019.
Data gathered during these dates suggested that Torrent’s investigation practices and procedures were ‘deficient’, in relation to its finished drug manufacture.
The report notes, “There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.”
It continued to suggest that the production of out-of-specifications APIs also resulted in ‘deficient’ investigations.
After the inspections and resulting observations, Torrent had to provide two updates to shareholders during a three-week period in April. Both inspections resulted in observations that required company action.
Torrent informed shareholders on both occasions: “We have received certain observations which are procedural in nature and the company is confident of addressing them satisfactorily.”
Recall adds to regulatory challenges
For Torrent, the Form 483 caps a difficult month for the company – with shares down 1.76% after the FDA public announcement and having fallen overall by 6% over the last four weeks.
Besides inspection troubles, the company also had to initiate a voluntary recall of 104 lots of losartan potassium tablets, after N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was discovered to be contaminating the medicine.
The ingredient was produced by Hetero Labs, which also supplied Teva with the same API, which led this company to also initiate a voluntary recall 35 lots of its losartan product.
To date, neither company has received any reports of adverse events related to the recalls.