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  5. Shadow Holdings dba Bocchi Laboratories - 561273 - 01/10/2020
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CLOSEOUT LETTER

Shadow Holdings dba Bocchi Laboratories MARCS-CMS 561273 —

Delivery Method:
United Parcel Service
Product:
Cosmetics
Recipient:
Recipient Name
Joseph C. Pender
Recipient Title
CEO/President
Shadow Holdings dba Bocchi Laboratories

26421 Ruether Ave
Santa Clarita, CA 91350-2621
United States

Issuing Office:
Division of Human and Animal Food Operations West V

United States

Dear Mr. Pender:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #561273 dated February 6, 2019. Based on our evaluation, it appears that you have addressed the violations 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/
Sergio Chavez, Compliance Branch Director
Office of Human and Animal Food Operations
West Division 5

 
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