- Crocker Spinal Technologies, Inc.
- Issuing Office:
Department of Health and Human Services
|Public Health Service|
|Food and Drug Administration|
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
March 24, 2016
President, Nexus CMF
2825 E. Cottonwood Pkwy., Ste 330
Salt Lake City, UT 84121
Dear Mr. Crocker:
The Center for Devices and Radiological Health, Office of Compliance, Division of Bioresearch Monitoring (DBM) issued a Warning Letter to your firm dated June 30, 2015 for failure to comply with the requirements under section 522 of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360I, which includes requirements specified under 21 CRF 822. Your response to the Warning Letter, dated July 13, 2015, acknowledged the need to comply with FDA’s 522 order (PS110002) and indicated that you had engaged the services of PaxMed International to conduct a review and improve interaction with the agency. PaxMed International provided an additional response to the Warning Letter on behalf of Nexus CMF, dated August 11, 2015. The response contained a proposed study design.
The Office of Surveillance and Biometrics (OSB) and the Office of Device Evaluation (ODE) have completed an evaluation of your firm’s Prospective Postmarket Surveillance Study Plan and your firm’s Explant Analysis Plan. An acceptance letter for these Study Plans was issued on March 16, 2016. Based on our evaluation, it appears that your firm has adequately addressed the violations contained in the Warning Letter.
This letter does not relieve your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 321(h), and its implementing regulations. The FDA expects your firm to maintain compliance and this letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.
James Saviola, OD, CAPT USPHS
Director, Division of Bioresearch Monitoring
Office of Compliance
Center for Devices and
Floyd G. Larson,
President, PaxMed International LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130