Inspectors from the US Food and Drug Administration (FDA) visited the production plant in Baddi, Himachal Pradesh in April and uncovered some of the same problems they encountered on a previous visit to the Indian site.
The inspectors accused Glenmark of failing to thoroughly investigate complaints about the grittiness of a topical cream.
From November 2017 to April 2019, Glenmark rejected 20 batches of the cream and received at least 38 complaints about the grittiness of the products. The FDA said the problems date back to 2010 and were identified during its previous inspection.
Glenmark Pharmaceuticals proposed a fix for the problem after the previous inspection but FDA found the response to be inadequate because it lacked the data needed to show the new formulation is robust.
The FDA warning letter blacks out the name of the affected product but states Glenmark recalled all batches in July 2019. Glenmark recalled tubes of mometasone furoate cream due to grittiness in July.
While the recall and remediation mean gritty products should no longer reach patients, the FDA said the “reformulation and market actions were not performed in a timely manner.”
This is one reason for the warning letter while another relates to Glenmark’s alleged failure to look into temperature excursions during shipping in the US in a timely manner.
The FDA called the inadequate investigation of temperature excursions “an ongoing issue.” Inspectors identified the same failing during the previous inspection of the Himachal Pradesh plant.
Glenmark responded to the FDA observation by vowing to run additional studies but the agency found the actions to be insufficient, noting that the company had failed to provide an adequate risk assessment.
Other sections of the warning letter identify failings in how the Baddi facility handled other quality deviations and complaints.
Glenmark received more than 70 consumer complaints about punctures, cracks and holes in multiple products but, according to the FDA, failed to properly evaluate the “serious container/closure system defects.”
In responding to the FDA, Glenmark argued the problems stemmed from “folding and refolding” by consumers and that the rate of complaints was low. The FDA deemed the response to be inadequate.
The plant is one of five of the company's finished product facilities approved by the FDA. Glenmark expects the facility to generate sales of $30m (€27m) this year, around 7% of all US sales, and believes performance will be unaffected by the warning letter.
The timing of the warning letter means it may not block future sales, either, as there are no “major” pending approvals related to the facility over the coming year, according to Glenmark.