For FDA investigators, there's no shortage of egregious errors to be found at drug manufacturing facilities around the world. But using aluminum foil and tape to catch stray bottle caps on the fill line? That's a new one, and the FDA isn't laughing it off.
Altaire Pharmaceuticals failed to ensure data integrity and used "tape and foil" to shore up a shoddy filling line at its Algonque, New York, sterile ophthalmic plant, the FDA wrote in a scathing warning letter published Tuesday.
During an inspection in late March 2019, FDA investigators found a raft of issues at Altaire's facility, including a lack of environmental controls in its aseptic processing area, "falsified" data records, improper work clothing and more. In July, the company recalled a slate of products made at the plant.
Some of the most egregious faults cited in the warning letter were tied to management oversight, the FDA said. For instance, the FDA said Altaire microbiologists were told by superiors only to finish pretesting documentation without following up.
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Despite bringing on a third-party consultants to address the issues, the FDA said Altaire hadn't adequately accounted for its prior flaws.
"Your failure to reliably record data, the systemic flaws that led to these fundamental data integrity breaches, and your lack of sufficient investigations into both, raises questions regarding integrity of data throughout your operation," the FDA wrote.
The FDA's note also showed that workers dressed in an unsafe manner on the job, risking sterility, and used ramshackle solutions to address manufacturing problems.
FDA investigators found workers used gloves sourced from a bulk bin rather than in individually wrapped packages and entered manufacturing areas with exposed skin due to "ill-fitting hoods and goggles." Altaire told the FDA it was sourcing new gloves and hoods and working on its gowning procedures.
Perhaps most egregious to investigators was a jerry-built tape-and-foil contraption on an Altaire fill line that workers erected to prevent bottle caps from falling into a hopper, the FDA wrote.
Investigators also found a portable cart used to carry finished products that was "stained." Altaire said it would remove the aluminum foil solution and identify the problems with its fill line that caused bottle caps to drop.
Despite the raft of issues and a letter promising to remedy them, Altaire did not go far enough to address the concerns, the FDA said, threatening legal action if the problems were not remedied.
"Although you stated you would establish and implement good documentation practices and data integrity procedures, you failed to address the pervasive nature of your firm’s practices of creating unreliable records and your lack of a quality culture," the FDA wrote.
Altaire's broad recall last July covered a number of its sterile ophthalmic products, including prescription and over-the-counter medicines. The drugmaker said the recall was directly tied to quality control issues at its New York plant.
It wasn't the first time Altaire had been forced to pull one of its products off the market. In 2013, Altaire recalled nine lots of ophthalmic solution sold under Walmart, CVS and Target brands after receiving complaints of mold found in its 30-milliliter bottles once they were opened.