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  1. Enforcement Actions (CBER)

Tri-State Biologics-Untitled Letter

September 20, 2013


Jonathan D. Tave, President
Tri-State Biologics Inc.
700 Plaza Drive
Suite 203
Secaucus, NJ 07094

Dear Mr. Tave:

During a Current Good Tissue Practice (CGTP) inspection by the Food and Drug Administration (FDA) of your contract manufacturer, --------------------------------------------------------------------------------(b)(4)------------------------------------------------------- from --------------------------------------, FDA investigators 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. We note that ----(b)(4)--------- manufactures and ships to Tri-State Biologics Inc. (Tri-State) an amniotic/chorionic based injectable product that is subsequently distributed by you.

You are currently registered with the FDA to store and distribute amniotic membrane products. The amniotic/chorionic-based injectable products from ---(b)(4)-------- are, among other things, intended for use in ---------(b)(4)---------, as well as for ---(b)(4)-------------------(b)(4)---------------. These ---(b)(4)----- amniotic/chorionic-based products are manufactured by -------------------(b)(4)-------------- amnion and chorion tissue, and then having the end user resuspend the product in normal saline for injection into ---(b)(4)-----.

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. The amniotic/chorionic-based injectable products manufactured by ------(b)(4)-------- and which you distribute do not meet the minimal manipulation criterion set forth in 21 CFR 1271.3(f)(1) due to the ----(b)(4)------- 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, these amniotic/chorionic-based injectable products 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)]. FDA has also contacted your contract manufacturer, -------(b)(4)-------, 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]. Your amniotic/chorionic-based injectable product 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.

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

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