Biostructures, LLC 10/7/10

Department of Health and Human Services	Public Health Service Food and Drug Administration
	Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415

 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

October 7, 2010

W/L 02-11

Mr. Russell L. Cook, CEO
Biostructures, LLC
3700 Campus Dr., Ste 204
Newport Beach, CA 92660-2603

 

Dear Mr. Cook:


During an inspection of your firm located in Newport Beach, California on May 12, 2010, through May 17, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures osteoMATRIX Synthetic Bone Graft Composite (b)(4), bone void filler devices and osteoMATRIX Mineralized Collagen Scaffold ((b)(4)). 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 are intended to affect the structure or function of the body.

Our inspection revealed that the osteoMATRlX Synthetic Bone Graft Composite (b)(4), bone void filler device is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 CFR 807.81(a)(3)(ii). Our inspection revealed that you are promoting and marketing the osteoMATRIX® Synthetic Bone Graft Composite in Part # (b)(4) Instruction for Use Rev (b)(4) brochure (b)(4) and http://www.biostructures.net/synthetic-bone-graft-composite.html for indications not cleared under K063527; these include but are not limited to use mixed with bone marrow aspirate, mixed with autograft bone, in hip and knee fractures/revisions, in high tibial plateau fractures, in foot/ankle fractures, in tibial and femoral osteotomies, as "grout" in shoulder arthroplasty, for "rapid bone remodeling", to maintain osteoprogenitor cells at the graft site, and other statements. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.

You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.

Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be sent to:

Blake Bevill
Director, Compliance Branch
Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506

If you have any questions about the content of this letter please contact: Dr. Raymond W. Brullo, Compliance Officer at (949) 608-2918.

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

Sincerely yours,
/S/
Alonza E. Cruse
Director, Los Angeles District
 

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