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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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High Performance Formulas, L.L.C. - Close Out Letter 4/24/12

  

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

Public Health Service
Food and Drug Administration
 

PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390

April 24, 2012

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Blaine Applegate, Owner
High Performance Formulas, L.L.C.
2001 Makefield Road
Yardley, PA 19067

Dear Mr. Applegate:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 12-PHI-11, dated March 22, 2012. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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 you firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and it 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/

Yvette Johnson
Compliance Officer
Philadelphia District