FDA blows up Syntec Pharma after importer stocks drug ingredients with antifreeze and weedkiller
It probably goes without saying that the ingredients of drugs should not be kept in the same room as dangerous chemicals like weedkillers and antifreeze. New York-based Syntec Pharma is learning this lesson the hard way.
FDA investigators slap Syntec, importer of pharmaceutical ingredients, with a long list of warnings about cleanliness, consistency and quality control issues at a New York plant. Syntec is also accused of failing to guard against cross-contamination and tampering with drug ingredients from companies on the FDA’s import alert list. The warnings come despite the company’s efforts to right the ship late last year.
Part of the problem is that Syntec simply did not design its facility “appropriately,” the FDA said in a warning letter posted online this week. The company responded to a previous FDA article in early December, but the regulator is still not satisfied. At the same time, Syntec temporarily suspended its repackaging operations, which were the focus of FDA complaints.
During an inspection of the company’s manufacturing plant in Farmingdale, New York, between October 7 and 28, 2020, investigators found that Syntec had failed to put the appropriate measures in place. to prevent cross-contamination of active pharmaceutical ingredients (APIs).
Syntec received, stored, weighed, repackaged and relabelled the drug ingredients in the same room using non-dedicated equipment and “without proper procedures,” the FDA said.
In addition, the company kept the API and packaging components in the same room as the weedkiller, engine antifreeze coolant and drywall repair products, the regulator said. As if that weren’t enough, investigators claimed that Syntec “mixed personal foods” and “unidentified products” in unlabeled foil bags in the same refrigerator where it kept drug ingredients and chemicals.
Syntec also told the regulator that it does not repackage very powerful APIs, but that was not true. The FDA discovered that it had tasked a customer to repackage cytotoxic chemotherapy lomustine.
When the regulator brought this to Syntec’s attention, the company admitted that it occasionally repackages very potent ingredients, but didn’t specifically remember how lomustine worked. This repackaging project lacked “basic documentation,” including a batch record and an equipment usage log, the FDA said.
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Previously, the company responded to the agency’s complaints by committing to divide its pharmaceutical storage area into four sections using separate shelves for cytotoxic compounds, beta-lactams, other potent compounds and others. API. The FDA says that’s not enough because Syntec has failed to come up with a plan to prevent cross-contamination and confusion.
Now the company will need to perform a retrospective risk assessment to determine whether any of the APIs it shipped was contaminated, as well as whether labeling errors may have occurred, the FDA said.
In addition to these concerns, the FDA says Syntec also has not established written cleaning procedures for its non-dedicated production equipment and has not documented the use and cleaning of reconditioning equipment.
The company also used laundry detergent rather than an appropriate cleaning agent to clean its ventilation hood, stainless steel spoons and scales, the FDA said.
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Syntec’s quality control unit is also in the crosshairs of the FDA. The company did not adequately test APIs before distribution and did not test its drug ingredients to confirm their quality, the regulator said. The company “relied solely” on evaluating a vendor’s clinical performance without doing their own review and as a result, Syntec released oxytocin tablets which were found to be super potent.
Finally, Syntec received drugs from three suppliers who were then on the FDA’s import alert list. A supplier’s drugs were reported because the company delayed, refused or limited FDA inspection of a foreign facility. Meanwhile, two of Syntec’s API providers have received their own warning letters.
Since Syntec has stopped manufacturing drugs at its Farmingdale plant, the FDA wants to know if it plans to “operate at this plant in the future.” If Syntec chooses to take this route, the regulator “strongly” recommends that it call on a consultant to help it meet FDA manufacturing standards.