August 28, 2013
FACSIMILE & UPS EXPRESS MAIL
Bill Taylor, President and CEO
Surgical Biologics, a MiMedx Group Company,
60 Chastain Center Blvd NW
Kennesaw, GA 30144
Dear Mr. Taylor:
During a Current Good Tissue Practice (CGTP) inspection of your firm, Surgical Biologics, a MiMedx Group Company, located at 60 Chastain Center Blvd. NW, Kennesaw, GA 30144, from July 30, 2012 to August 1, 2012, investigators from the Food and Drug Administration (FDA) collected information on the manufacture of a number of amniotic/chorionic-based products. This information was provided to the FDA’s Center for Biologics Evaluation and Research (CBER) for review.
You are currently registered with the FDA to recover, screen, package, process, store, label and distribute these products. You distribute some of these products directly as a MiMedx Group Company and act as a contract manufacturer for the other products. The FDA is contacting these other distributors under separate cover. These products include: AmnioFixTM Injectable, AccelShieldTM Injectable (Accel Spine), ---(b)(4)---------------------------------------, and EpiFixTMInjectable, all of which are intended for use, among other things, in reducing inflammation and scar tissue formation, as well as for enhancing wound healing of soft tissues.
These micronized amniotic/chorionic-based products are manufactured by ----(b)(4)------- dehydrated composite amnion and chorion tissue, and then having the end user resuspend them in normal saline for injection into soft tissues. Injectable amniotic/chorionic-based products are human cells, tissues, and cellular and tissue-based products (HCT/Ps) as defined in 21 CFR 1271.3(d). However, these products are HCT/Ps that do not meet all of the criteria in 21 CFR 1271.10(a) and therefore are not regulated solely under section 361 of the Public Health Service Act (PHS Act) and the regulations in 21 CFR Part 1271. Specifically, the products do not meet the minimal manipulation criterion set forth in 21 CFR 1271.3(f)(1) due to the micronization process which alters the original relevant characteristics of the structural tissue, relating to the tissue’s utility for reconstruction, repair or replacement. As a result, your HCT/Ps are drugs as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and biological products as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)].
Please be advised that in order to lawfully market a drug that is also a biological product, a valid biologics license must be in effect [42 U.S.C. 262(a)]. Such licenses are issued only after a showing of safety and efficacy for the product’s intended use. While in the development stage, such products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect as specified by FDA regulations [21 U.S.C. 355(i); 42 U.S.C. 262(a)(3); 21 CFR Part 312]. None of the amniotic/chorionic-based products described in this letter are the subject of an approved biologics license application (BLA), nor are there INDs in effect for any of these products. Based on this information, we have determined that your actions have violated the Act and the PHS Act.
This letter is not intended to be an all-inclusive review of the products that your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and the PHS Act and their implementing regulations.
We request that you notify this office, in writing, of the steps you have taken or will take to address the violations noted above and to prevent their recurrence. Your response should be sent to me at the following address: U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200 N, Rockville Maryland 20852-1448.
If you have any questions regarding this matter, you may contact Dr. Jessica Kostick at (301) 827-6201. Please be advised that only written communications are considered official.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research