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Regulatory Focus™ > News Articles > 2021 > 8 > Antifreeze and APIs don't mix, FDA tells Syntec

Antifreeze and APIs don't mix, FDA tells Syntec

Posted 03 August 2021 | By Joanne S. Eglovitch 

Antifreeze and APIs don't mix, FDA tells Syntec

The US Food and Drug Administration has warned New York-based pharmaceutical manufacturer Syntec for a litany of good manufacturing practice (GMP) problems. The agency says that issues related to how the firm handles active pharmaceutical ingredients (API) compromise the safety of the drugs produced at the site.
Among the problems found by FDA at the firm’s site in Farmingdale, NY, were inadequate contamination safeguards, as well as lax cleaning and testing procedures.
The 6 July letter that followed FDA’s October 2020 inspection of the Syntec facility was released Tuesday. It found an overall lax approach to contamination controls in handling API.  Investigators found that Syntec was storing both Lomustine and human chorionic gonadotrophin (HCG) at room temperature instead of at the manufacturer-required refrigerated temperatures. Lomustine is a highly potent cytotoxic chemotherapy agent, making the risk of degradation from the too-warm temperatures particularly concerning.
During the inspection, Syntec denied repackaging Lomustine, though records indicated otherwise. After being called out by FDA, the firm acknowledged “occasionally” performing repackaging, while not specifically remembering its Lomustine repackaging activity.
The firm also kept weed killer, engine antifreeze coolant, and dry wall repair products in the same room with APIs, thus compromising their safety. FDA inspectors also found that personal food items and unidentified products in unlabeled aluminum bags were commingled with APIs and other chemicals in the refrigerator where API and chemicals were stored.
“The drugs distributed by your firm were at risk for contamination and other hazards to drug safety because you failed to appropriately design your facility, establish effective procedures, maintain records for your activities, and implement robust controls,” wrote FDA.
In its initial response to the inspection findings, Syntec stated that it planned to separate cytotoxic compounds, beta-lactams, other potent compounds and APIs into four separate areas by using separate shelves for storage of each type of drug. FDA said this response was insufficient because the firm failed to provide an appropriate corrective action and preventive action (CAPA) plan for preventing cross-contamination and other mix-ups.
Failure to establish written procedures
The firm was also criticized for using a laundry detergent instead of an “appropriate” cleaning agent, to clean its ventilation hood, utensils and balances; no cleaning validation studies, equipment use logs, or records were kept.
Syntec also failed to adequately test API prior to release and distribution, relying solely on the supplier’s certificate of analysis without qualifying the analysis. As a result, superpotent lots of Oxytocin lots were released to a customer.
Also, three of the firm’s API suppliers were subject to an import alert at the time the company imported their ingredients to Syntec. FDA said that ingredients from two of the API suppliers were listed on the import alert for failure to conform to GMPs, while one supplier was placed on an import alert for delaying or limiting an FDA inspection.
FDA encouraged the firm to hire a GMP consultant, and requested a response within 15 working days of receipt of the warning letter.
The firm has since suspended manufacturing of drugs as well as repackaging operations. FDA requested it be informed before Syntec resumes operations.
Syntec Pharma warning letter


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Tags: APIs, FDA, letters, warning