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  5. Human Biologics of Texas/Globus Medical - 557325 - 08/28/2023
  1. Warning Letters

CLOSEOUT LETTER

Human Biologics of Texas/Globus Medical MARCS-CMS 557325 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Biologics
Recipient:
Recipient Name
Mr. Daniel Scavilla
Recipient Title
President/CEO
Human Biologics of Texas/Globus Medical
Tissue Transplant Technology, Ltd.

2560 Armistead Avenue
Audubon, PA 19403
United States

Issuing Office:
Los Angeles District Office

United States

Dear Mr. Scavilla:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, OBPO #19-01, issued October 30, 2018, directed towards your human cells, tissues, or cellular or tissue-based products (HCT/Ps) that meet all the criteria in 21 CFR 1271.10(a) for regulation solely under section 361 of the Public Health Service Act (PHSA) [42 U.S.C. 264]. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,
/S/
Marc Jackson, Compliance Officer
U.S. Food and Drug Administration
Office of Biological Products Operations, Division II
Compliance Branch
Marc.Jackson@fda.hhs.gov

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