Inspections, Compliance, Enforcement, and Criminal Investigations

SCS Direct Inc. - Close Out Letter 9/11/17

 

  

Black HHS-Blue FDA Logo

 

 

 
 

September 11, 2017

Via UPS Next Day Air Saver
With Signature Confirmation

Howard Greenspan, President
SCS Direct Inc.
Holding Company of MD MOM® LLC.
9 Trefoil Dr.
Trumbull, CT 06611-1330

Dear Mr. Greenspan:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 495961 dated October 18, 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/

Maya M. Davis
Compliance Officer
Division of Pharmaceutical Quality Operations 1 

Page Last Updated: 09/11/2017
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