In a setback for Indoco Remedies, the pharma company informed that it has received a warning letter from the USFDA for its facility in Goa's Verna region on December 17, sending the shares sharply lower by up to 6% before recovering marginally.
The facility II and III at the Verna plant had received an Official Action Initiated (OAI) status from the USFDA on October 11, after an inspection between July 16-26 earlier this year.
During 2023 as well, the USFDA has issued observations under Form 483, following inspection of Indoco's Goa facility.
Indoco Remedies said it is in touch with the regulator regarding matter. "We will work with the USFDA to resolve these issues at the earliest," Indoco added.
When the USFDA identifies 'significant violations' of federal requirements, it notifies the manufacturer in the form of a Warning Letter. This communication identifies the concern which may range from poor manufacturing practices, problems with products' claims, or incorrect directions for use. The letter offers a chance for the company to address USFDA's concerns and seeks a time-bound response. As per USFDA, this response could be proposed corrections, which the regulator would then check, to ensure if they are adequate.
Track Indoco's September quarter results here.
"...our technical teams are in continuous dialogue with USFDA to try and understand their
concerns and understand how we have to move forward now," Indoco had said during the September quarter earnings call, when asked about the Goa plant's remediation.
According to Indoco, its Goa facility manufactures for US, and the Baddi plant will make for Europe, while Bharuch will manufacture for emerging markets, as per company's plan to have an agile operation.
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