Inspections, Compliance, Enforcement, and Criminal Investigations
Revival Animal Heath, Inc. Warning Letter Response 2
1700 Albany Place SE
PO Box 200
Orange City, IA 51041
|Phone: (712) 737-5555
Fax: (712) 737-8512
March 28, 2006
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 response is a follow up to your letter postmarked March 7, 2006. I left you a voice mail on March 23, 2006 that a response was forthcoming. You acknowledged with a voice message that same day this time frame was acceptable to you. Upon review of the comments on your letter dated March 7, 2006 please see the subsequent responses. These responses are based upon information provided to me by Revival staff members. On March 16, 2006 Revival made website changes as stated below:
(1) Epinephrine Injectable : this product on the website has been removed. The catalog information regarding this product, which is scheduled to be `in home' in June 2006, will be sold only as a prescription product, if included at all.
(2) Lincocin Injectable: the website has been corrected to remove the wording from the dog and cat sections. The catalog information regarding this product, which is scheduled to be `in home' in June 2006, will also be corrected.
(3) Pyrante150mg: the website wording has been corrected. The catalog information regarding this product, which is scheduled to be `in home' in June 2006, will also be corrected.
(4) Albon Soluble Powder: the website subcategories have been corrected. The catalog information regarding this product, which is scheduled to be `in home' in June 2006, will also be corrected.
(5) Parasite control for cats: Revival has corrected the website to remove those subcategory links regarding 'other label use.'
(6) Review of entire product inventory and advertising for compliance: Revival has completed the review to insure compliance with the regulations and has made changes to the website on March 16, 2006 . The appropriate catalog pages will also be modified that will be mailed starting June 2006. And finally, Revival has instituted a standard operating policy (SOP) to review wormer, medication, and vaccine labels in insure correct presentation on our website and future catalogs. The marketing analyst [redacted] will conduct this periodic review.
The intent is to answer your questions completely. Please contact us if additional clarification is needed. We will await your response in this regard.
For Revival Animal Heath, Inc.
1700 Albany Place SE
Orange City, Iowa 51041