CLOSEOUT LETTER

Sheryl Gibbs August 09, 2016

Recipient:: Sheryl Gibbs; United States

Issuing Office:: United States


Department of Health and Human Services	Public Health Service Food and Drug Administration
	PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215-597-4390

Delivered Via United Parcel Service

August 9, 2016

Sheryl Lynn Gibbs, Founder
Sevani Botanica
315 Overlook Lane
Conshohocken, PA 19428

Dear Ms. Gibbs:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 16-PHI-08, issued on July 19, 2016. 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/
Steven L. Carter
Director, Compliance Branch
Philadelphia District Office

Department of Health and Human Services