FDA WARNING_LETTER - Carolina Liquid Chemistries Corp - November 09, 2018

An FDA inspection of Carolina Liquid Chemistries Corp. in Brea, CA, from November 5-9, 2018, revealed violations regarding their Class I and II in-vitro diagnostic reagents. The firm manufactures and distributes devices including Tapentadol Reagent Kit ST431, Zolpidem (Zolp) Reagent Kit ST428, Spice Kit, and Fentanyl (Fent) Kit.

These products are deemed adulterated under section 501(f)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because the firm lacks approved applications for premarket approval (PMA) or investigational device exemptions. They are also misbranded under section 502(o) of the Act for failing to submit a premarket notification (510(k)).

Specifically, the Tapentadol, Zolpidem, and Fentanyl reagents, labeled "for forensic use only," were distributed to a pain management center and a clinical testing laboratory, with no evidence of forensic use. The Spice reagent, labeled "for research and development use only," was distributed to a pain management center, again without evidence of the stated use. This issue of shipping devices labeled for restricted use to inappropriate entities was previously discussed during inspections in June 2017 and November 2018.

The firm must notify the FDA in writing within fifteen business days of receiving the letter