Inspections, Compliance, Enforcement, and Criminal Investigations

Aegeia Skin Care, LLC - Close Out Letter 5/17/18

 

  

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Office of Human and Animal Food Operations West Division 3
4040 North Central Expressway, Suite 300
Dallas, Texas 75204

May 17, 2018

UPS OVERNIGHT

Ms. Rebecca S. Wachsler, Owner
Aegeia Skin Care, LLC
3128 Nasa Road 1
Seabrook, TX 77586

Dear Ms. Wachsler

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter 2017-DAL-WL-12 dated February 17, 2017. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA surveillance and regulatory activities could 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. If you choose to reestablish or sale your operations, 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/

Jessica E. Hensley
Director of Compliance Branch, OHAF-W3 

Page Last Updated: 06/12/2018
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