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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gulf Marine & Industrial Supplies, Inc. Response Letter

June 20, 2006

U.S. Food and Drug Administration

Attention: Rebecca A. Asente, Compliance Officer

6600 Plaza Drive, Suite 400

New Orleans, LA 70127

Re: Formal Response to Warning Letter No. 2005-NOL-19

Dear Ms. Asente:

This letter serves as our formal response to your Warning Letter No. 2005-NOL-19.  Great progress has been made in our pest control program.  As a result, there has been no evidence of rodent activity in our facilities.  This has been proven by the March 24th, 2006, inspection by the same FDA inspector, Mr. David R. Heiar, who had inspected us in January of 2005.  We scored a 97 out of 100 points, with no evidence of rodent activity.  We have contracted with [REDACTED] a known expert in rodent and pest control and FDA compliance, who has guided us in achieving these goals.  He has also undertaken the task of heading up our Quality Control Program.  The Louisiana State FDA has also inspected us and given us a clean bill of health.

We have screened all windows with fine mesh screen and closed up all other openings.  We are constantly on guard that no new openings occur, that would provide entry for rodents.  We have stepped up our use of rodent glue boards and rodent baits.  Our efforts have proven successful.

In addition, we have an ongoing program of moving stock away from walls and painting white borders along the walls.  This will take time to complete, but we have made progress.  The damage and disruption caused by Hurricane Katrina afforded us the opportunity to repair the walls and floors in the refrigerators and freezers.

Finally, a fresh supply of paper towels is being maintained in the restrooms.

While the infestation in your letter was noted in a small area of our [REDACTED] warehouse, we understand that any infestation is a problem.  We will continue to work in all the ways described above on that area as well as the rest of the warehouse. 

Thanks for your cooperation.

Respectfully yours,

/S/

Stephen J Cotsoradis

Secretary-Treasurer

Enclosure—FDA Report of  March 24, 2006