Glenmark Facility Draws Warning for Complaint Investigations
The FDA issued a warning letter to Indian API and generics manufacturer Glenmark for multiple violations at its Baddi, Himachal Pradesh plant, including incomplete investigations of complaints.
The facility received at least 38 complaints over grittiness of a topical cream since November 2017 but didn’t sufficiently investigate them, the agency said, adding that the cream’s gritty texture has been a consistent problem since 2010.
The firm’s investigations into more than 70 complaints of punctures, holes and cracks in drug products failed to address the cause of the product flaws. The company concluded that the flaws were caused by improper folding and refolding by consumers, but more than 50 of the complaints were closed without any corrective and preventive actions.