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  5. Belmora LLC - Close Out Letter7/19/17
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Belmora LLC


Belmora LLC

 

  

Black HHS-Blue FDA Logo

 

Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455

 
 

July 19, 2017

Reference: CMS# 521015

Ms. Jamie Belcastro, President and Founder
Belmora, LLC
2231 Crystal Drive, Unit 100
Arlington, VA 22202

Dear Ms. Belcastro:

On July 19, 2017, The Food and Drug Administration completed an evaluation of your firm’s corrective actions in response to our Warning Letter (#521015), dated June 8, 2017. 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 the 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 Rochelle B. Young, RPh, MSA
Compliance Officer

cc:

Lisa Capote
Capote Law Firm