Inspections, Compliance, Enforcement, and Criminal Investigations
Revival Animal Heath, Inc. Warning Letter Response
1700 Albany Place SE
PO Box 200
Orange City, IA 51041
Phone: (712) 737-5555
Fax: (712) 737-8512
December 16, 2005
RETURN RECEIPT REQUESTED
Mr. Joseph G. Kramer, Compliance Officer
U.S. Food and Drug Administration
11630 W. 80th Street
Lenexa, Kansas 66214
Ref: KAN 2006-03
This letter is a follow up to your letter postmarked November 22 and received in our office on Monday, November 28 (after the holiday weekend). Since then we have taken prompt action and started our internal investigation.
Your letter states a response is necessary within 15 working days of receipt of the warning letter. It also states that if corrective action cannot be completed in that timeframe, a letter stating the reasons should be sent. We have not completed all of the corrective actions as of this date primarily because we need additional clarification from your office.
To insure we are in compliance with your instructions we are submitting this letter and other information.
Our specific actions include:
(1) A letter dated December 6, 2005, requesting a telephone conference. Our purpose for the conference is to seek clarification of corrective actions. Our goal is to respond promptly and insure that the actions meet FDA expectations. This conference has been scheduled with Mr. William Bargo of the Rockville, Maryland office on December 20, 2005, at 11:00 a.m. CST.
(2) On December 16, 2005, we made website revisions based upon suggestions in your letter dated November 21. Please find enclosed copies of those revisions.
(3) We have informed our marketing department of these changes and will make the necessary corrections in future catalog development.
We look forward to resolving these issues as quickly as possible. The telephone conference on December 20, 2005, will be extremely helpful.
We request 30 days from the date of this letter to follow up with your office. Please advise us with your expectations.
For Revival Animal Heath, Inc.
1700 Albany Place SE
Orange City, Iowa 51041