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CLOSEOUT LETTER

Blue Ridge Pharmacy and Compounding Center Jun 14, 2016

Blue Ridge Pharmacy and Compounding Center - Close Out Letter 6/14/16


Blue Ridge Pharmacy and Compounding Center

  

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

Public Health Service
Food and Drug Administration
Atlanta District
 60 8th street, N.E.
Atlanta. GA 30309
Telephone (404) 253-1161
Fax          (404) 253-1202

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

June 14, 2016

Ms. Wendy L. Haun
Pharmacist/Owner
Apex Family Pharmacy dba Blue Ridge Pharmacy and Compounding Center
2601 Blue Ridge Road
Raleigh, NC 27607-6481


Dear Ms. Haun:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our warning letter (ref: 14-ATL-06) dated April 30, 2014. 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 compliance with the Federal Food, Drug, and Cosmetic Act and FDA's 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/

lngrid A. Zambrana
Atlanta District Director