Inspections, Compliance, Enforcement, and Criminal Investigations
Bollinger Quick Repair, Inc. 14-Dec-01
DEPARTMENT OF HEALTH AND HUMAN SERVICE
Food and Drug Administration
New Orleans District
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
December 14, 2001
WARNING LETTER NO. 2002-NOL-15
Mr. Boysie Bollinger, Chariman/CEO
Bollinger Quick Repair, Inc.
8365 Highway 308
South Lockport, Louisiana 70374
Dear Mr. Bollinger:
We conducted an inspection of your potable watering point facility, located at 615 Destrehan Avenue, Harvey, Louisiana, on November 27, 2001. The inspection was conducted under the authority of the Public Health Service Act (pHSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).
At the conclusion of the inspection, Form FDA 483 (Inspectional Observations) and Form FDA 2521 (Inspectional Summary) were issued to Mr. Hank Santos, Safety & Environmental, citing violations of the Interstate Conveyance Sanitation Regulations, Title 21, Code of Federal Regulations, Parts 1240 and 1250 (21 CFR 1240 and 1250). During the inspection, the following violations were noted:
- Eight of your potable water outlets located on the same manifold as the non-potable water outlets are not identified for their intended use; and,
- Your potable water hydrants are not constructed in a manner that prevents contamination of the water. For example, your hydrants are not equipped with caps and keeper chains,
The same inspectional observations, identified above, were brought to your firm?s attention during FDA?s inspection of your facility on May 5, 1998.
The inspectional observations are not intended to be an all-inclusive list of the deficiencies that may exist. As a result of these deficiencies, this facility has been classified as "Provisional. " A Provisional classification means the facility may continue to operate; however, significant correction of violations must be made within thirty days. Another inspection will be conducted within 30 days to determine if the deficiencies have been adequately corrected. If acceptable corrections have been made, the facility will be returned to an "Approved" classification. If corrections are unacceptable, a "Not Approved" classification will be assigned. Interstate conveyance vessels are prohibited from using watering points that have been classified as "Not Approved" in accordance with 21 CFR 1250.60.
During the inspection, Mr. Santos reported to our investigator that he would correct the
deficiencies by December 4, 2001. You should take prompt action to correct the deficiencies. It is your responsibility, as a servicer of interstate conveyance vessels, to ensure that all requirements of the PHSA and the FD&C Act are being met.
You should notify this office in writing, within 15 working days of receipt of this letter, of the actions taken to correct the deficiencies and to assure that such violations will not recur. If you cannot correct the deficiencies within the required timeframe, we expect you to explain in writing the reason for the delay and provide a date by which You will correct any remaining deficiencies.
Your response should be addressed to the U.S. Food and Dmg Administration, Attention: Mr. Mark W. Rivero, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, you may direct them to Mr. Rivero at the above address or at 504-253-4519.
Carl E. Draper
New Orleans District