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  5. Reproductive Technologies, Inc. - 594292 - 12/03/2021
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CLOSEOUT LETTER

Reproductive Technologies, Inc. MARCS-CMS 594292 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
#OBPO 20-594292
Product:
Biologics

Recipient:
Recipient Name
Ms. Alice H. Ruby
Recipient Title
Executive Director
Reproductive Technologies, Inc.

2115 Milvia Street
Suite 201
Berkeley, CA 94704
United States

Issuing Office:
Office of Biological Products Operations - Division 2

United States


Dear Ms. Ruby:

The Food and Drug Administration has completed evaluation of Reproductive Technologies, Inc.’s corrective actions in response to our Warning Letter #OBPO 20-594292 dated November 6, 2019. 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/
Young Mi Yoon
Compliance Officer
Division 2 Compliance Branch
Office of Biological Products Operations (OBPO)
Office of Regulatory Affairs
U.S. Food and Drug Administration

 
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