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  5. Asclemed USA Inc dba Envoachem Pharmeceuticals - 575542 - 03/02/2020
  1. Warning Letters

CLOSEOUT LETTER

Asclemed USA Inc dba Envoachem Pharmeceuticals MARCS-CMS 575542 —

Delivery Method:
VIA UPS
Product:
Drugs
Recipient:
Recipient Name
Robert Nickell
Recipient Title
President/CEO/Owner
Asclemed USA Inc dba Envoachem Pharmeceuticals

379 Van Ness Ave
Suite 1403
Torrance, CA 90501
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

United States

949-608-2900

Dear Mr. Nickell:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 575542, dated June 11, 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 verify your written commitments.

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/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV

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