Specifically, the FDA states Syntec has critical issues with how the pharmaceutical manufacturer handles active pharmaceutical ingredients, issues that may compromise the safety of the firm’s manufactured drugs.
Al Drago/CQ Roll Call
In a recent warning letter from the U.S. Food and Drug Administration (FDA), the agency has alerted Syntec regarding problems related to its good manufacturing practices (GMPs). Specifically, the FDA states Syntec has critical issues with how the pharmaceutical manufacturer handles active pharmaceutical ingredients (API), issues that may compromise the safety of the firm’s manufactured drugs.
According to the FDA, Syntec’s Farmingdale, New York, site isn’t up to par in terms of its cleaning and testing procedures. In addition, the firm’s site features inadequate contamination safeguards, further compromising the potential safety of its products.
The letter, published publicly on Tuesday, was dated July 6 and followed an October 2020 inspection of Syntec’s facility by the FDA. Agency investigators found the pharmaceutical manufacturing firm stored human chorionic gonadotrophin (HCG) and Lomustine at room temperature, but the manufacturers for these products required them to be stored at refrigerated temperatures. Lomustine, a potent cytotoxic chemotherapy, is especially at risk of degradation from warm temperatures, making its storage at Syntec’s facility of particular concern to the FDA.
Syntec denied repackaging Lomustine during the inspection; however, the firm eventually said it “occasionally” performed repackaging as cited by the FDA. Despite this acknowledgment, Syntec didn’t necessarily recall its repackaging activity for Lomustine.
In addition to the Lomustine repackaging issues, Syntec also stored engine antifreeze coolant, dry wall repair products and weed killer in the same vicinity as APIs, further deepening the agency’s safety concerns over the firm’s handling of the pharmaceutical ingredients. Inspectors at the FDA also said they identified personal food items, in addition to products in unlabeled aluminum bags, among APIs and other chemicals stored in a refrigerator.
“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 the FDA in its warning letter to Syntec.
Syntec said in an initial response to the agency that it planned to separate APIs, beta-lactams, cytotoxic compounds and other potent products into four different areas. To accomplish this, the firm said it would use separate storage shelves designated for each drug type. According to the FDA, however, this response from Syntec wasn’t sufficient, given the firm didn’t take the appropriate corrective and preventive action to prevent cross-contamination, among other issues.
FDA inspectors also criticized Syntec for relying on laundry detergent to clean its facility rather than using an “appropriate” cleaning product. Additionally, Syntec reportedly kept no equipment use logs, cleaning validation studies or cleaning records.
In the warning letter, the FDA encourages Syntec to hire a GMP consultant to address the cited issues. The agency also requested Syntec to respond to the warning letter within a 15-working-day period from letter receipt. Since it received the letter, Syntec has suspended drug manufacturing operations and drug repackaging.
This isn’t the first time Syntec has experienced a run in with the FDA. Way back in 2011, U.S. Marshalls seized dietary supplements and drugs manufactured by the firm due to false claims made about their efficacy and safety in relation to the treatment of numerous diseases.
