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. Bio-Botanica, Inc. - 370519 - 12/10/2018
  1. Warning Letters

CLOSEOUT LETTER

Bio-Botanica, Inc. MARCS-CMS 370519 —


Recipient:
Recipient Name
Frank D’Amelio, Jr.
Recipient Title
President
Bio-Botanica, Inc.
Bio-Botanica, Inc.

85 Commerce Drive

Hauppauge, NY 11788
United States

Issuing Office:

United States


Dear Mr. D’Amelio:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter NYK-DO 2013-20 dated May 29, 2013 issued to Nature’s Answer, a subsidiary of Bio-Botanica, Inc. 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 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/
CDR Catherine M. Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1