Inspections, Compliance, Enforcement, and Criminal Investigations
Macco Organiques, Inc. - Close Out Letter 3/10/14
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
|Office of Manufacturing and Product Quality|
Division International Drug Quality
International Compliance Branch
10903 New Hampshire Avenue
Building #51, Room 4312
Silver Spring, MD 20993
TELEPHONE: (301) 796-8859
FAX: (301) 847-8742
March 10, 2014
Macco Organiques, Inc.
100 Rue McArthur
Valleyfield, Quebec, Canada J6S4M5
Reference: FEI 3002807518
Dear Mr. Rinella:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-11-005 dated December 10,2010. Based on our evaluation, it appears that you have 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 subsequent inspection or through other means.
Mary D. Davis-Lopez
Division of International Drug Quality