Inspections, Compliance, Enforcement, and Criminal Investigations

Balmer Brothers - Close Out Letter 1/4/16

  

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

FOOD AND DRUG ADMINISTRATION
PHILADELPHIA DISTRICT
 900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106

Telephone: 215-597-4390

January 4, 2016


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Cletus Balmer, Partner
Balmer Brothers
1102 Breneman Road
Manheim, PA 17545

Dear Mr. Balmer:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 15-PHI-08, dated January 14, 2015. 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/

Steven L Carter
Director, Compliance Branch
Philadelphia District Office

Page Last Updated: 01/06/2016
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