Inspections, Compliance, Enforcement, and Criminal Investigations
J & F International, Inc - Close Out Letter 12/13/10
| 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 |
Department of Health and Human ServicesFEI: 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
