It should probably go without saying that drug ingredients ought not be kept in the same room as dangerous chemicals like weedkiller and antifreeze. New York-based Syntec Pharma is learning that lesson the hard way.
FDA investigators slapped drug ingredient importer Syntec with a laundry list of warnings over cleanliness, consistency and quality control issues at a New York factory. Syntec is also charged with failing to safeguard against cross-contamination and dabbling 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 comes down to the fact that Syntec simply didn’t design its facility “appropriately,” the FDA said in a warning letter posted online this week. The company had responded to a previous FDA write-up in early December, but the regulator still isn’t satisfied. Meanwhile, Syntec has temporarily paused its repackaging operations, which were at the center of the FDA’s complaints.
During an inspection of the company’s Farmingdale, New York, manufacturing plant between Oct. 7 and Oct. 28, 2020, investigators found that Syntec didn’t put appropriate measures in place to prevent cross contamination of active pharmaceutical ingredients (APIs).
Syntec received, stored, weighed, repackaged and relabeled drug ingredients all in the same room using non-dedicated equipment and “without appropriate procedures,” the FDA said.
Further, the company kept API and packaging components in the same room as weedkiller, engine antifreeze coolant and dry wall repair products, the regulator said. As if that weren’t bad enough, investigators claimed Syntec “comingled personal food items” and “unidentified products” in unlabeled aluminum bags in the same fridge where it kept drug ingredients and chemicals.
Syntec also told the regulator that it doesn’t repackage highly potent APIs, but that wasn’t true. The FDA found it had charged a customer to repackage the cytotoxic chemotherapy lomustine.
When the regulator brought that to Syntec’s attention, the company admitted it occasionally repackages highly potent ingredients but didn’t remember the lomustine work specifically. That repackaging project lacked “basic documentation,” including a batch record and equipment use log, the FDA said.
Previously, the company responded to the agency’s complaints by pledging to split its pharmaceutical storage area into four sections using separate shelves for cytotoxic compounds, beta-lactam, other potent compounds and other APIs. The FDA says that isn’t good enough, because Syntec failed to establish a plan to prevent cross-contamination and mix-ups.
Now, the company will need to perform a retrospective risk assessment to figure out whether any of the APIs it shipped out were contaminated, plus whether any labeling mix-ups may have occurred, the FDA said.
Aside from those concerns, the FDA says Syntec also failed to establish written cleaning procedures for its non-dedicated production equipment and failed to document the use and cleaning of repackaging equipment.
The company also used laundry detergent rather than an appropriate cleaning agent to clean its ventilation hood, stainless steel spoons and balances, the FDA said.
Syntec’s quality control unit is also in the FDA’s crosshairs. The company didn’t appropriately test APIs before distribution and didn’t test its drug ingredients to confirm their quality, the regulator said. The company “relied solely” on a supplier’s clinical outcome assessment without doing its own review, and, as a result, Syntec released oxytocin tablets that were found to be super-potent.
Lastly, Syntec received drugs from three suppliers that were on the FDA’s import alert list at the time. Drugs from one supplier had been flagged because the company had delayed, denied or limited the FDA’s inspection of a foreign facility. Meanwhile, two of Syntec’s API suppliers have been hit with warning letters of their own.
Given that Syntec has stopped manufacturing drugs at its Farmingdale plant, the FDA wants clarification on whether it plans to “conduct any operations at this facility in the future.” If Syntec chooses to go that route, the regulator “strongly” recommends it enlist a consultant to help meet the FDA’s manufacturing standards.