CLOSEOUT LETTER
Eric Cherne
- Recipient:
- Eric Cherne
United States
- Issuing Office:
United States
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Office of Human and Animal Food – West Division II 8050 Marshall Drive - Suite 205 Lenexa, Kansas 66214-1524 913-495-5100 |
April 26, 2018
DELIVERY VIA UPS
WARNING LETTER CLOSE-OUT LETTER
Scott N. Cherne, Owner
Eric Cherne, Owner
33166 Kiln Road
Guttenberg, IA 52052
Dear Mr. Scott Cherne and Mr. Eric Cherne:
The Food and Drug Administration has completed an evaluation of Eric Cherne corrective actions in response to our Warning Letter (CMS case #: 497714) on June 27, 2016. 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/
Miguel A. Hernandez
Director, Compliance
Office of Human and Animal Food – Division II West