After an inspection uncovered issues earlier this year, the FDA issued an import alert to one of Sun Pharma’s drug manufacturing facilities in Gujarat, India, jeopardizing shipments from the plant to the U.S. market.
The admonishment by the regulatory agency implies that all future shipments of drugs made at the Halol facility could be barred from entry into the U.S. until the plant becomes compliant with the FDA standards, the company said in a Dec. 8 filing (PDF) with the Bombay Stock Exchange.
The FDA excluded 14 products from the import alert subject to certain conditions. The company didn’t disclose which products those are. The import warning came in the wake of an inspection conducted between April 26 and May 9.
“The company continues to cooperate with the U.S. FDA and will undertake all necessary steps to resolve these issues and to ensure that the regulator is completely satisfied with the company’s remedial action,” Sun said in the filing.
The Halol facility accounted for about 3% of Sun Pharma’s consolidated revenues for the year ended March 31, the company said. Those numbers include the 14 unnamed products not affected by the FDA alert.
Back in May, the FDA hit Sun Pharma with a Form 483 that cited 10 observations following an inspection by the agency at the Halol facility in Gujarat. That action was the result of an inspection that began April 26 and ended May 9 and appears to have triggered the import warning.
In June, Sun Pharma initiated a voluntary recall of 50,680 vials of testosterone cypionate injection because of “water leakage” at one of its plants in Gujarat, India. The company has several manufacturing facilities located in Gujarat.