August 28, 2013
UPS EXPRESS MAIL
Paras Patani, CEO
Castle Surgical, LLC.
251 East 32nd Street
New York, NY 10128
Dear Mr. Patani:
During a Current Good Tissue Practice (CGTP) inspection of your contract manufacturer, 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 Center for Biologics Evaluation and Research (CBER) for review. One of the products manufactured by Surgical Biologics is provided to you and distributed as AmnioFix Injectable.
You are not currently registered with the FDA to store and distribute AmnioFix Injectable. AmnioFix Injectable is, among other things, intended for use in reducing inflammation and scar tissue formation, as well as for enhancing wound healing of soft tissues. This micronized amniotic/chorionic-based product is manufactured by -----(b)(4)----- dehydrated composite amnion and chorion tissue, and then having the end user resuspend the product 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, your AmnioFix Injectable does 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, AmnioFix Injectable is a drug as defined under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)] and a biological product as defined in section 351(i) of the PHS Act [42 U.S.C. 262(i)]. The FDA is also contacting your contract manufacturer, Surgical Biologics, under separate cover, regarding this matter.
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]. AmnioFix Injectable is not the subject of an approved biologics license application (BLA), nor is there an IND in effect. Based on this information, we have determined that your actions have violated the Act and the PHS Act.
We also note that manufacturing of HCT/Ps, including storage and distribution requires registration with the FDA under 21 CFR part 1271 subpart B. We note that Castle Surgical is not registered under part 1271 nor are your HCT/Ps listed with the FDA
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