FDA slaps drug re-packager in NY with warning letter

Aug. 5, 2021

No, you’re not supposed to store API in the employee refrigerator, the FDA recently had to point out to Syntec Pharma Corp.

In a warning letter detailing a number of quality violations — which was sent July 6 but posted by the agency this week — Syntec failed to control cross-contamination of APIs held at its Farmington, NY facility. 

In one of the most forehead-slapping examples of quality lapses, the FDA pointed out that in particular, Syntec kept common chemicals — including weed killer, engine antifreeze coolant and drywall repair products — in the same room as certain API and packaging components. During an inspection, a similar situation was found involving food.

“You also comingled personal food items and unidentified products in unlabeled aluminum bags in the refrigerator where you stored your API and chemicals,” the agency said.

The FDA also dinged the company for saying it did not store high-potency API products — but then later admitting that it did repackage a cytotoxic chemotherapy agent. Naturally, this particular point showcased that the company also failed to keep adequate written records, another issue raised by the agency in its letter. 

In addition, the FDA said the company’s cleaning procedures were not up to snuff and that it was not performing adequate testing of the API passing through its facility. Syntec has 15 days to respond to the letter, and the agency has recommended that the company hire a CGMP consultant.