- Delivery Method:
- VIA UPS
Recipient NameRobert Nickell
- Asclemed USA Inc dba Envoachem Pharmeceuticals
379 Van Ness Ave
Torrance, CA 90501
- Issuing Office:
- Division of Pharmaceutical Quality Operations IV
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.
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV