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FDA Warns Carolina Liquid Chemistries About Improper Use of Reagent Kits

NEW YORK – The US Food and Drug Administration issued a warning letter to Carolina Liquid Chemistries after finding that certain of the company's products were not being used properly and lacked proper 510(k) clearance from the agency.

In the warning letter dated July 31 and posted on FDA's website on Tuesday, three products from CLC were supposed to be used for forensic use only or research and development use only. However, FDA found that there was no evidence that they were being used as intended.

The products cited by the agency are CLC's tapentadol reagent kit ST431, lot number 11666; CLC720 zolpidem reagent kit ST428, lot number 11433; spice kit, lot number J1814; and fentanyl kit, lot number E1815. The products, FDA said, "lack a premarket notification/510(k) or premarket approval/PMA."

Specifically, CLC's tapentadol, zolpidem, and fentanyl reagent devices are distributed with instructions that say they should be for forensic use only. The tapentadol and zolpidem reagents were distributed to a San Antonio, Texas pain management center, while the fentanyl reagent was distributed to a clinical testing laboratory in Linden, New Jersey, but "there is no evidence that these reagents are used by these firms 'for forensic use only,'" the FDA said in its warning letter.

Similarly, CLC's spice reagent devices are meant to be for research and develop use only, but they were distributed to a pain management center in Dryden, New York. "There is no evidence that this reagent is used by that firm 'for research and development use only,'" the FDA said. It also noted in its warning letter that during an inspection in November 2018 of the company's manufacturing facility in Brea, California, the agency determined that CLC manufactures and distributes Class I and II in vitro diagnostic reagents.

CLC is headquartered in Greensboro, North Carolina.

Cheryl Andrews, a lawyer for CLC, said in an interview that the FDA has said that the company’s products were labeled properly. Since being warned by the agency, the company has implemented a program in which customers must sign a certification letter saying they are using its products as intended.

It is awaiting a response from FDA to the steps it has taken, she added.