Inspections, Compliance, Enforcement, and Criminal Investigations
Cephazone Pharma, LLC - Close Out Letter 6/21/12
| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612M2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesVIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
June 21, 2012
Mr. Avinash Ghanekar, Director of Operations
Cephazone Pharma, LLC
250 East Bonita Ave
Pomona, CA 91767
Dear Mr. Ghanekar:
The Food and Drug Administration has completed an evaluation of your written responses to the FDA483, results of our inspection conducted November 17, 2011, and corrective actions to our Warning Letter [WL # 34-11], dated April 25, 2011. Based on our evaluation, it appears that you have addressed the violation(s) contained in the 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/
Alonza E. Cruse, Director
Los Angeles District
