It would be logical to think that India’s Wockhardt would be on top of all of its manufacturing given the long list of warning letters and import alerts the FDA has doled out to it in recent years. That is not the case. Wockhardt has been slapped with yet another warning letter, this time for a sterile manufacturing plant in the U.K. that has been cited before.
The letter, which was issued a week ago and posted Tuesday, in general points out how the CP Pharmaceuticals plant in Wrexham is failing to make sure its drugs are safe from contamination.
The drugmaker disclosed (PDF) the warning letter to investors in a filing with the Bombay Stock Exchange the day after it was filed by the FDA, saying CP is not currently shipping product to the U.S. and that Wockhardt has already started addressing the issues raised by the FDA.
“Currently, there is no business being conducted from CP Pharmaceuticals to the US market. CP Pharmaceuticals has already initiated required steps to address the concerns raised by the US FDA and will be responding to the agency within the prescribed time,” Wockhardt said in a stock exchange filing.
The drugmaker just last month announced it was investing $12 million to build a sterile manufacturing and testing facility at its site in Wrexham, adding 50 jobs, but didn't mention the site was on the cusp of another regulatory rebuke.
Among other problems at the cited facility, the FDA said that operators were frequently seen touching surfaces like pushcarts and then performing tasks in the ISO 5 sterile area without first disinfecting their hands. “The ISO 5 is a critical area because sterile product is exposed and therefore vulnerable to contamination,” the letter pointed out.
The facility also didn’t routinely disinfect the cart that held items, even after it had been stored for extended periods. There also was poor monitoring of some workers doing aseptic setup, even though that was an issue cited in a 2010 warning letter, the FDA said.
“Based upon the nature of the violations we identified at your firm and because you failed to correct repeat violations, we strongly recommend engaging a consultant qualified,” the FDA told the Indian drugmaker.
Wockhardt has seen a series of FDA actions since 2013, when the agency banned two Wockhardt plants in India that were key to its U.S. business, actions that took a big toll on the Indian company. Wockhardt Chairman Habil Khorakiwala last year told investors the company hoped to get those two plants again approved for U.S. exports in 2016, something that has yet to happen. The remarks came a day after the Indian drugmaker reported that sales in the U.S. last fiscal year were off by 50%. Then last summer, the FDA banned a third Wockhardt plant in India, deepening its problems.