U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Custom Compounding Centers, LLC - Close Out Letter 12/15/15
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Custom Compounding Centers, LLC


Custom Compounding Centers, LLC

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
Los Angeles District
 19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax          (949) 608-4415

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED


December 15, 2015

Paul R. Wheeler, Pharm. D.
President and Pharmacist in Charge
Custom Compounding Centers, LLC
10525 Humbolt Street
Los Alamitos, CA 90720


Dear Dr. Wheeler:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our warning letter (ref: WL # 39-13) dated May 15, 2013. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.

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.


Sincerely,

/S/

LCDR Steven Porter, Acting Director
Los Angeles District