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. Unique EnCapsulation Technology LLC - 506356 - 02/08/2019
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Unique EnCapsulation Technology LLC MARCS-CMS 506356 — Feb 08, 2019

Unique EnCapsulation Technology LLC - 506356 - 02/08/2019

Product:
Food & Beverages

Recipient:
Recipient Name
K.G. Rao
Recipient Title
Founder & CEO
Unique EnCapsulation Technology LLC

9 Lenel Road
Landing, NJ 07850
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

6000 Metro Drive
Suite 101
Baltimore, MD 21215
United States

(410) 779-5455

Dear Mr. Rao,

On November 8, 2018, the Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to our Warning Letter (#506356) dated January 17, 2017. Based on our evaluation of your most recent inspection that was concluded November 8, 2018, it appears that you have addressed the violations contained in the 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. If you have any questions related to this letter, I can be contacted via email at rochelle.young@fda.hhs.gov or by phone at 410-779-5437.

Sincerely,
/S/
CDR Rochelle B. Young, RPh. MSA
Office of Human & Animal Food East Division 2
Compliance Officer