Inspections, Compliance, Enforcement, and Criminal Investigations
Manolo and Son, LLC - Close Out Letter 10/26/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
October 26, 2011
Return Receipt Requested
Ms. Joan A. Ribadulla, Co-Owner
Manolo and Son, LLC
1230-B N. Henry Street
Alexandria, VA 22314
Dear Ms. Ribadulla:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS 180377 dated May 16, 2011. Based on our evaluation, it appears that you have adequately addressed the violation(s) 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.