Inspections, Compliance, Enforcement, and Criminal Investigations
Queseria Chipilo, Inc. - Close Out Letter 11/8/11
| Public Health Service Food and Drug Administration |
Waterview Corporate Center |
Department of Health and Human ServicesTelephone (973) 331-4906
November 8, 2011
Via UPS
Mr. Emilio Cuautle
President
Queseria Chipilo, Inc.
61 Willet Street, Bldg. F 2nd Floor
Passaic, NJ 07055
Dear Mr. Cuautle:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter Number 11-NWJ-13, dated March 3, 2011. 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 a subsequent inspection or through other means.
Sincerely,
/s/
Joseph McGinnis
Acting Director, Compliance Branch
New Jersey District
