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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Missa Bay, LLC - Close Out Letter 7/24/13

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
New Jersey District Office
Central Region
Waterview Corporate Center
10 Waterview Blvd. 3rd Floor
Parsippany, NJ 07054
Telephone: (973) 331-4902

 

VIA UNITED
PARCEL SERVICE


July 24, 2013


Mr. Michael Solomon
President/Chief Executive Officer
Missa Bay, LLC
4401 Foxdale Avenue
Irwindale, CA 91706


Dear Mr. Solomon:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter, file number 13-NWJ-04. 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/

CAPT Joseph F. McGinnis
Director, Compliance Branch
New Jersey District


cc: Mr. Ernie DiDominick
      Acting Director of Operations
      Missa Bay, LLC
      101 Arlington Boulevard
      Swedesboro, NJ 08085