Inspections, Compliance, Enforcement, and Criminal Investigations
Ramona's Mexican Food Products, Inc. 07-Sep-06
Department of Health and Human Services
Public Health Service
Los Angeles District
RETURN RECEIPT REQUESTED
September 7, 2006
Ramona A. Banuelos, President
Ramona's Mexican Food Products, Inc.
13633 South Western Avenue
Gardena, CA 90249
Dear Ms. Banuelos:
The Food and Drug Administration conducted an inspection of your facility located at 13633 South Western Avenue, Gardena, California on May 22-24, 2006. At the conclusion of the inspection, you were issued a Form FDA 483, List of Inspectional Observations, which delineated a number of insanitary conditions observed in your food manufacturing facility. These conditions cause the food products produced in your facility to be adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 342(a)(4)), in that they were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or may have been rendered injurious to health. You can find the Act through links on the FDA's homepage at www.fda.gov.
The following is a list of insanitary conditions observed by our investigator during the inspection.
1. Your employees did not wash and sanitize their hands prior to handling product. [21 CFR 110.10(b)(3)] Specifically, on 5/22/06, two employees were observed handling in-process food without first washing their hands.
2. Your plant is not constructed in such a manner as to prevent drip and condensate from contaminating food. [21 CFR 110.20(b)(4)] Specifically, there was condensate dripping from the refrigerator condensers directly into open totes of chopped onions and chopped bell peppers in cooler "1", directly into an open tote of shredded lettuce in one of the "deli" coolers, and directly into an open tote of cooked ground beef in cooler "#3".
3. You failed to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of food-contact surfaces. [21 CFR 110.35(a)] Specifically, the ends of four horizontal multi-nozzle sprayers inside all three compartments of your conveyer-type dishwashing machine were closed with soiled tape. Further, on 5/22/06, an employee was observed handling raw egg yolks while wearing latex gloves and then washing the processing equipment and utensils while wearing the same latex gloves (i.e. without changing gloves) or washing the gloves with running water, soap and/or sanitizer.
4 . You failed to maintain equipment so as to facilitate cleaning of the equipment. [21 CFR 110.40(a)] Specifically, connections on a corn kernel feed line to a rooftop hopper were joined with tape, and a feed line from the rooftop corn kernel hopper to a processing area kettle was also held together with tape.
5. Your plumbing constitutes a source of contamination to equipment and utensils. [21 CFR 110.37(b)(3)] Specifically, on 5/22/06, the ends of two hoses (dishwashing room and tortilla processing area) were in direct contact with the wet, soiled floor. In addition, the faucets for these two hoses did not have back- flow prevention devices.
6 . You failed to maintain building repairs to prevent food from being adulterated. [21 CFR 110.35(a)]. Specifically, on 5/22/06, open containers of in-process food and soaking corn kernels were directly under peeling ceiling paint and plaster. In addition, open trays of cooked potatoes and open buckets of cooked beans and other ingredients were under peeling paint near a scale in the main processing area next to the deli door.
The above violations are not meant to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations of the FDA. You should take prompt action to correct the violations observed during FDA's most recent inspection. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should include each step that has been taken to completely correct the current violations and to prevent the recurrence of similar violations, the time within which correction will be completed, and any documentation necessary to show that the correction has been achieved. If corrective actions cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.
Your written reply should be addressed to:
Pamela B. Schweikert
Director of Compliance
U.S. Food and Drug Administration
Irvine, CA 92612-2506
Alonza E. Cruse