India’s Alkem Laboratories, already dealing with concerns raised by EU regulators over one plant, now says the FDA has issued more than a dozen observations at one of its other key facilities.
In a filing with the Bombay Stock Exchange, Alkem reported that a two-week FDA inspection at its plant in Daman concluded on Thursday with a Form 483 that listed 13 observations. Alkem gave no details of the findings but simply said that it would put together a detailed response “with adequate corrective and preventive measures to address the US FDA Observations” and send it to the FDA within the agency’s stipulated timeframe.
Earlier this year, the U.K.'s Medicines and Healthcare Products Regulatory Agency said an inspection of the company's Alkem’s Taloja site found instances of data falsification. In that case, Alkem also said it would respond to regulators' concerns as the MHRA requested.
The FDA has had issues with Alkem before. In 2014, it sent U.S. marshals into a warehouse in Ohio to seize more than $11 million worth of drugs made by Alkem subsidiary Ascend Laboratories, including skin creams, ear drops and a treatment for inflamed hemorrhoids. It accused Alkem Laboratories of selling the products in the U.S. without ever getting approvals for them and said it had warned the drugmaker it needed approvals following an inspection.
- here’s the BSE filing