Inspections, Compliance, Enforcement, and Criminal Investigations
Konec Inc. - Close Out Letter 3/16/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Silver Spring, MD 20093-0002
March 16, 2011
Attention: Mr. George Krsek, Owner
3840 E. 44th Street, # 609
Tucson, Arizona 85713
Re: Sublingual Nitroglycerin Tablets, 0.3 mg, 0.4 mg, and 0.6 mg
Dear Mr. Krsek:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated March 16, 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 implementation of regulations or with other relevant legal authorities. 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.
Michael M. Levy., Jr., Esq.
Division of New Drugs and Labeling Compliance