Inspections, Compliance, Enforcement, and Criminal Investigations
Tembec BTLSR Inc Response Letter
Tembec BTLSR Inc.
Tembec Resin Group
2112 Sylvan Ave.
PO Box 2570
Toledo, OH 43606
Telephone: (419) 244-5856
Fax: (419) 244-9206
October 3, 2007
Carol A. Heppe
U.S. Food and Drug Administration
6751 Steger Dr.
Cincinnati, OH 45237-3097
Re: Warning Letter CIN-DO 07-33572-18
Dear Ms. Heppe:
Please accept this letter as Tembec BTLSR Inc.'s ("BTLSR") response to the Warning Letter dated September 11, 2007 (the "Warning Letter"). The Warning Letter simply reiterated the findings in the FDA 483 and only requested as additional action that BTLSR confirm in writing, by an official authorized to make the decision, that BTLSR permanently discontinue manufacturing and marketing of RW26, RW25, and UP60 (the "Products") as aquatic feed binder. As requested, the undersigned is an official authorized to make this decision and this letter confirms BTLSR's prior decision to do so.
Although we are not aware of any potential for adverse health effects to humans or animals, we took this recall very seriously.(1) We responded immediately with corrective action in the form of a complete recall of the Products. At the same time we made the decision to permanently discontinue production of these products and exit the aquatic feed binder market.
Immediate Corrective Action Taken
On May 30, 2007 we initiated a voluntary recall of all of the product codes and lots of the Products manufactured since February 2004. We have been working closely with the FDA recall coordinator in the Cincinnati District Office to conduct the recall in compliance with all applicable rules and regulations. We will continue to work with the FDA recall coordinator until the recall is complete.
Final Corrective Action
We took a definitive approach to correct the FDA 483 observations. We ceased all production and distribution of the shrimp feed binder products by May 19, 2007 and decided to immediately exit the aquatic shrimp feed binder business.
We have taken the items noted in the FDA 483, and repeated in the Warning Letter, very seriously and we are standing by our decision to no longer produce the Products for shrimp feed binder applications. Additionally, we have no plans to produce any products at our facility that are or could be regulated by the FDA. Please note that FDA Form 3537a, to cancel our FDA registration, was submitted on October 2, 2007.
We believe that our thorough and prompt corrective action in recalling the product and ceasing production and distribution completely addresses all of the concerns set forth in the Warning Letter. Based on the foregoing, we would appreciate the posting of this response on the FDA's website showing that the matter has been properly resolved.
Randy Fournier, President
Tembec BTLSR Inc.
cc: Karen Gale Sego, Compliance Officer
The FDA's May 30,2007 Press Release also concluded that the products in question were unlikely to pose a threat to human health.