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. Coenzyme A, Inc. - 540210 - 11/06/2018
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Coenzyme A, Inc. MARCS-CMS 540210 — Nov 06, 2018

Coenzyme A, Inc. - 540210 - 11/06/2018

Delivery Method:
Overnight Delivery

Recipient:
Recipient Name
Nickolaos D. Skouras
Recipient Title
President
Coenzyme A, Inc.
Coenzyme A, Inc.

12512 Beverly Park Road
Suite B1
Lynnwood, WA 98087
United States

Issuing Office:

22215 25th Avenue SE
Suite 210
Bothell, WA 98021
United States


Dear Mr. Skouras:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 540210, dated January 5, 2018. 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/
Miriam R. Burbach
District Director
Program Division Director