• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

J & F International, Inc - Close Out Letter 12/13/10

 

  

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

Public Health Service
Food and Drug Administration
 Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
Fax: (410) 779-5703

FEI: 3005848804

 

December 13, 2010

 

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Farzana Kennedy, Co-Owner
J&F International Inc., dba Alexandria Medical Arts Pharmacy & Compounding Laboratory
315 South Washington Street
Alexandria, VA 22314

Mr. John Ayele, Co-Owner
J&F International Inc., dba Alexandria Medical Arts Pharmacy & Compounding Laboratory
315 South Washington Street
Alexandria, VA 22314

Dear Ms. Kennedy and Mr. Ayele:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 74925 dated April 9, 2010. Based on our evaluation, it appears that your firm has 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/

Anne Aberdeen
Compliance Officer
Baltimore District