Here is a link to the original FDA warning letter from March 12, 2010 -- regarding Vetsulin® (porcine insulin zinc suspension), manufactured by Intervet Inc., a subsidiary of Merck, in Unterschleissheim, Germany. Below is the FDA's close-out letter, in full text:
Department of Health and Human Services
Public Health Service
Food and Drug AdministrationRockville MD 20857
September 13, 2010
Mr. Raul E. Kohan
Executive Vice President
and President Animal Health,
Merck & Co., Inc.
2000 Galloping Hill Road
Kenilworth, NJ 07033
Dear Mr. Kohan:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, March 12, 2010. Based on our evaluation, it appears that you have 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/
Neal Bataller, ME, DVM
Director, Division of Compliance
Center for Veterinary Medicine
Not unexpected, but good news for Intervet, just the same.
2 comments:
This doesn't mean that Intervet has solved the manufacturing issue, it means Intervet has taken appropriate corrective action with respect to the reporting violations contained in the original letter. Vetsulin remains on product alert, i.e. Intervet is not back in the market with Vetsulin yet.
Quite so, Anon.
You are absolutely right -- so I have made yours a new post, right here, along with the FDA's release on Vetsulin®, as of May 5, 2010.
Thanks for the better information, and the correction, sincerely!
Namaste -- do keep coming back!
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