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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Love and Quiches Desserts Response Letter

July 27, 2005

To: Mr. Bruce A. Goldwitz
Compliance Officer
Food and Drug Administration

From: Jeff Gruber
Director of Quality Assurance and Food Safety

Date: 7/30/04

Subject: Response to Warning Letter
Reference: NYK-2004-22

Mr. Goldwitz,

Since the May 6th & 10th, 2004 inspections of our facility by Investigator Ortiz-Latinsky, much has progressed in the way of Food Safety. I will reference each C.F.R deficiency as stated in your warning letter and the corrective action we have instituted. They are as follows:

1. Per 21 C.F.R. 110.37 (b)(5) and 1250.30(d), our facility did not have a backflow -prevention device on the main water line and the Straham hoses in the pots and pans and dishwashing area.
Corrective Action - During the week of 5/16/04 a Backflow Prevention device was installed on the main water line. On 5/26/04, the line was inspected by([redacted]) and was found to meet the requirements of an acceptable containment device. (See enclosed copy of NYS Dept. of Health Form 1013)
During the week of 5/16/04, our maintenance department installed backflow prevention devices on the Straham hoses in the pots and pans and dishwashing area.

2. Per 21 C.F.R. 110.37(e) and 1250.38, failure to provide adequate hand washing facilities with running water at suitable temperatures.

Corrective Action - Since the time of the inspection, we have installed 2 new additional sinks in the production areas. We have also taken a look at the production logistical layout, and have made some minor consolidation changes, that greatly improve organizational flow and department accessibility. This means, that hand washing facilities have been increased and placed more efficiently where they are needed most. The maintenance department has also made corrective repairs to assure those stations that did not have hot water, are now piped with hot water to assure proper temperature.

3. Per 21 C.F.R. 110.35(d)(5) and 1250 .33 there was a failure to have safe and adequate sanitizing agents that render equipment and utensils clean and provide
sufficient cleaning and sanitizing treatment.
Corrective Action - All sinks in the 3 sink washing stations located through the production areas that were missing a drain stoppers now have them in place. Personnel in the pots and pans washing area have been re trained in the proper method of a 3-sink system and how to keep the sanitizing sink at proper strength levels . We have also designated at lead person for that area to head up the organizational flow and procedural upkeep of that area.

4. Per 21 C.F.R. 110.80(b)(3) and 1250.27 citing failure to prevent rapid growth of micro organisms, specifically pasteurized eggs, that were left out un refrigerated
during lunch breaks.
Corrective Action - All mixing department personnel were instructed not to leave scaled eggs out during breaks. Routine inspection of the area during breaks indicates associates are following this food safety handling procedure.

5 . Per 21 C.F.R. 110.37(a) and 1250.30(c), failure to have a water supply for the operation intended. The water flow pressure should be between 15 &25 psi. The final rinse gauge for the dishwashing machine should be at 180 F. The wash temperature gauge of the dishwashing machine was inoperable. The dishwashing
machine was not provided with an ips valve.

Corrective Action - Our maintenance department walked me through the corrections that they performed to the dishwashing machine. They showed me the water flow pressure gauge that was reading 20 psi. The final rinse gauge for the dishwasher was reading at 165 degrees. (Maintenance indicated this was the maximum temperature that they could achieve with the hot water tank set at 220 degrees. At 165 degrees this should provide a kill step.) The wash temperature gauge was repaired and was indicating a temperature of 145 degrees. I was also shown an ips valve where the inspector could set in his or her own gauge and turn a valve to verify a pressure reading.

Since joining the Love and Quiches team here back in Mid April of '04, my transition into the company was to take the Food Safety items to the next level. We have taken these observations and this warning letter seriously. Since the time of the inspection, we began initiating corrective action. Please review this response letter and let us know if our actions meet your requirements . If you have any further concerns or need us to answer anything further, please let us know.

Sincerely Yours,

Jeffrey Gruber
Jeff Gruber
Director of Quality Assurance and Food Safety