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CLOSEOUT LETTER

Proper Nutrition Inc. MARCS-CMS 612435 —

Delivery Method:
VIA UPS
Product:
Food & Beverages

Recipient:
Recipient Name
Dr. Leonard C. Giunta
Recipient Title
President
Proper Nutrition Inc.

439 S. Bolmar Street
West Chester, PA 19382-4933
United States

Issuing Office:
Human and Animal Food Division II East

United States


Dear Dr. Leonard C. Giunta,

The Food & Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter with CMS#612435, dated April 20, 2021. 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/
Daniel W. Johnson
Compliance Officer
HAF Division East 2, Philadelphia Office
Office p hone: 215.717.3746
e-mail: Daniel.Johnson@fda.hhs.gov

 
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