An FDA warning letter is an ignominious sign for any company and a wake-up call for change. But two warning letters in one year? That's an alarm bell for most companies—a fact that a Pennsylvania-based drugmaker is finding out the hard way after a new FDA notice.
FDA investigators accused KVK-Tech of failing to set up the proper policies to surfaces used in packaging operations at its Newtown, Pennsylvania plant despite the agency's prior wrist slap in April, according to a warning letter [addressed to
Anthony P. Tobasso, President and CEO] posted online this week.
During an inspection between February and March, investigators found the company did not have proper cleaning protocols for a slat table used in packaging its oral solid-dose drugs, which were redacted in the letter.
The newest warning letter isn't KVK's first run-in with the FDA—a point investigators noted.
In February, the FDA found KVK failed to properly integrate co-eluting peaks during impurity testing of its phentermine HCL capsules, a drug used for weight loss, at a second facility in Newtown. As a result, the letter says the analysis failed to detect out-of-specification results for at least one lot of the drug.
KVK Tech said even though its methods might underestimate impurities in the drug, the impact was minimal because “the failing batches were ultimately recalled from the market, albeit at a potentially later time.”
The FDA, unimpressed by this argument, ordered the company to bring in an independent consultant to help it assess its laboratory practices and then put together a plan on how it intends to bring them up to agency expectations.
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The Newtown Bucks County Joint Sewer Authority previously had issues with how waste water from KVK Tech is handled. It may have to take another look! These chemicals are NOT what we want to end up in our ground water.
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