WARNING LETTER

Carolina Liquid Chemistries Corp MARCS-CMS 573596 — July 31, 2019

Delivery Method:: VIA UNITED PARCEL SERVICE
Product:: Medical Devices

Recipient:: Recipient Name

Mr. Philip Shugart; Recipient Title

CEO/President; Carolina Liquid Chemistries Corp; 575 N. Patterson Ave. Ste 430
Winston Salem, NC 27101-4178
United States

Issuing Office:: Center for Devices and Radiological Health; United States

WARNING LETTER

July 31, 2019

Dear Mr. Shugart:

During an inspection of your firm located in Brea, CA from November 5 to 9, 2018, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures and distributes Class I and II in-vitro diagnostic reagents. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

Your Tapentadol Reagent Kit ST431 Lot #11666, CLC720 Zolpidem (Zolp) Reagent Kit ST428 Lot #11433, Spice Kit Lot #J1814, and Fentanyl (Fent) Kit Lot #E1815 appear to lack a premarket notification/510(k) or premarket approval/PMA. Our review of your labeling concludes that your Tapentadol, Zolpidem, and Fentanyl reagent devices are distributed with Instructions for Use that states “for forensic use only”. However, you distributed the Tapentadol and Zolpidem reagents to a firm in San Antonio, Texas that is a pain management center. You distributed the Fentanyl reagent to a clinical testing laboratory in Linden, New Jersey. There is no evidence that these reagents are used by these firms “for forensic use only”. In addition, our review of your labeling concludes that your Spice reagent devices are distributed with Instructions for Use that states “for research and development use only”. However, you distributed this reagent to a firm in Dryden, New York that is a pain management center. There is no evidence that this reagent is used by that firm “for research and development use only”.

Therefore, your Tapentadol, Zolpidem, Spice, and Fentanyl devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have any approved applications for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or any approved applications for investigational device exemptions under section 520(g) of the Act, 21 U.S.C. § 360j(g).

The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Finally, we note that during the inspections conducted in June 2017 and November 2018, a discussion occurred between our investigator(s) and your firm concerning your prior and continued shipment in interstate commerce of devices labeled as either “for forensic use only” or “for research and development use only". We have no evidence that you have shipped to appropriate research institutions, law enforcement agencies, or court mandated testing centers.

Please notify FDA in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.

Your firm’s response to this letter should reference CMS case # 573596 be sent to BOTH:

Food and Drug Administration
Center for Devices and Radiological Health
Office of Product Evaluation and Quality
Office of Regulatory Programs
Division of Regulatory Programs 2: Establishment Support
Regulatory Inspections and Audits Team
White Oak Building 66, Rm 3657
10903 New Hampshire Ave.
Silver Spring, MD 20993

AND

oradevices3firmresponse@fda.hhs.gov

If you have any questions about the content of this letter please contact Tara Goldman, Compliance Officer at 301-796-6197 or via e-mail tara.goldman@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations and take prompt actions to correct the violations and bring the products into compliance.

Sincerely yours,

/S/
Timothy T. Stenzel, M.D., Ph.D.
Director
Office of In Vitro Diagnostics and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC:

Mr. Renato Peña, Vice President/General Manager
Carolina Liquid Chemistries Corp
510 W. Central Ave. Ste. C
Brea, CA 92821-3032