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CLOSEOUT LETTER

INCELL Corporation LLC MARCS-CMS 491621 —

Delivery Method:
UPS EXPRESS
Reference #:
2017-DAL-WL-02
Product:
Drugs

Recipient:
Recipient Name
Mary P. Moyer
Recipient Title
President & Chief Science Officer
INCELL Corporation LLC

12734 Cimarron Path
San Antonio, TX 78249-3424
United States

Issuing Office:
Center for Drug Evaluation and Research

United States


Dr. Moyer:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s response to our warning letter (ref: WL # 2017-DAL-WL-02). We acknowledge that, in response to our warning letter, you have chosen to de-register your facility and discontinue operations as a 503B outsourcing facility. We note that de-registration was completed on December 30, 2016.

Should your firm decide to resume production of drug products, FDA strongly recommends that you undertake a comprehensive assessment of your operations, and that you notify FDA prior to resuming drug production. You are expected to take all necessary steps to assure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

If you have questions regarding the contents of this letter, please contact John W. Diehl at (214) 253-5288.

Sincerely,
/S/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II

 
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