CLOSEOUT LETTER
Peter Thomas Roth Labs, LLC MARCS-CMS 495984 —
- Recipient:
- Peter Thomas Roth Labs, LLC
United States
- Issuing Office:
United States
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Office of Human and Animal Food Operations East |
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September 18, 2017
Peter Thomas Roth, Founder
Peter Thomas Roth Labs, LLC
460 Park Ave.
New York, New York 10022-1906
Dear Mr. Roth:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter NYK-2016-40 dated July 22, 2016. 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 Beer
Acting Director, Compliance Branch
Office of Human and Animal Food Operations East Division 1