Dive Brief:

• FDA has hit Carolina Liquid Chemistries with a warning letter for allegedly distributing Class I and II in-vitro diagnostic reagents without regulatory authorization.

• In a letter published Tuesday, FDA said Carolina Liquid sold reagents branded only for forensic or research and development use to pain management centers and a clinical testing laboratory.

• FDA found no evidence Carolina Liquid’s Tapentadol, Zolpidem, Spice and Fentanyl reagent devices were only used in restricted, nonclinical contexts.

Dive Insight:

Carolina Liquid has FDA clearance to sell a range of products, including tests for cocaine and HDL cholesterol. However, as the North Carolina-based company states on its website, it also has a range of assays that have not been cleared by FDA. Carolina Liquid labels those assays for forensic or research use only.

FDA is concerned the tests are being used outside of forensic and research applications. Inspectors visited Carolina Liquid around one year ago and raised concerns about the sales history of reagents branded as for forensic or research use only.

"We have no evidence that you have shipped to appropriate research institutions, law enforcement agencies or court mandated testing centers," FDA wrote in the warning letter last year. But now the agency now says Carolina Liquid has shipped its tests to a pain management firms. 

FDA said Carolina Liquid shipped Tapentadol and Zolpidem reagents to a pain management center in Texas and the Fentanyl reagent to a clinical testing laboratory in New Jersey. The reagents' instructions for use state they are for forensic use only but the pain management center and clinical testing laboratory may have used them for other purposes.

FDA raised similar concerns about the distribution of Spice reagent devices Carolina Liquid labeled for research and development use only. Carolina Liquids shipped that reagent to a pain management center in New York. 

"There is no evidence that this reagent is used by that firm 'for research and development use only,'" FDA said in its new warning letter.  ​​

Inspectors discussed the "prior and continued shipment in interstate commerce" of reagents without FDA clearance during inspections in 2017 and again last year during the visit that triggered the warning letter. FDA sent the warning letter in July but only made it public this week. 

The warning letter is the latest in a series of letters issued to companies over shipping devices without first obtaining premarket approval. In 2019, FDA has issued and published seven warning letters related to the failure of companies to obtain clearance to distribute a medical device or diagnostic. FDA issued one warning letter related to premarket approvals in all of 2018.