Inspections, Compliance, Enforcement, and Criminal Investigations
Gloria's Pantry 6/3/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
San Francisco District
June 3, 2011
Louis C. Clinton, Owner
2551 S Rodeo Gulch Road
Soquel, CA 95073
Dear Mr. Clinton:
The Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility located at 2551 South Rodeo Gulch Road, Suite 2, Soquel, California, from January 13, 2011 through February 2, 2011. The inspection revealed serious violations of Title 21 of the Code of Federal Regulations (CFR) Part 110 - FDA's Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations. In addition, an environmental sample collected during the inspection found Listeria monocytogenes (L. monocytogenes) on a direct food contact surface, a plastic bowl used to hold lettuce. Because your food products have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or may have been rendered injurious to health, the products manufactured in your facility are 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)]. Yon may find the Act and FDA's regulations through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which documented insanitary conditions present in your facility at the time of the inspection. Your CGMP violations included the following:
1. Failure to assure that food contact surfaces are maintained to protect food from being contaminated as required by 21 CFR 110.40(a). Specifically, a plastic bowl used to hold cleaned lettuce was cracked and repaired with tape. This precludes the adequate cleaning and sanitizing of this food contact surface. FDA's environmental sample from the inside of this bowl found the bowl to be contaminated with Listeria monocytogenes, a known pathogenic microorganism.
2. Failure to maintain buildings, fixtures, and other physical facilities in a sanitary condition as required by 21 CFR 110.35(a). Specifically, a packing table, floors, and walls in the processing area were observed to be encrusted with food particles and other debris, and cobwebs were observed in skylights directly over food preparation areas.
3. Failure to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices to the extent necessary to protect against contamination of food as required by 21 CFR 110.10(b). Specifically, employees were observed using their non-gloved hands to process food products with exposed rings and nail polish and while wearing exposed long sleeved street clothes; storing personal clothing, drinking cups and other personal belongings in the same area in which spring rolls were prepared; eating an apple while preparing carrots, an ingredient of the spring rolls; and preparing sambosas without wearing an effective hair restraint.
4. Failure to handle in-process food in a manner that protects against contamination as required by 21 CFR 110.80(b)(5). Specifically, uncovered, exposed sambosa filling was being cooled next to a roll up door which leads directly to a driveway.
We acknowledge receipt on April 20, 2011 of your firm's response to the Form FDA-483, Inspectional Observations issued to you on February 2, 2011. Your response fails to adequately address the violations noted above. Your response states that sanitation rules will be posted, however the response fills to include a copy of the rules. In addition, your response fails to assure that food handlers and supervisors will receive appropriate training in proper food handling techniques and food-protection principals. Furthermore, your response fails to assure that a competent supervisory person will be assigned to verify compliance and proper implementation of your corrective actions. Your response also states that the cracked bowl has been discarded, but you fail to address any actions to be taken to assure that equipment and facilities are maintained in a sanitary condition. In addition, we acknowledge that you made assurances to our inspector at the time of the inspection that certain violations would be corrected. However, you have not provided adequate documentation verifying those verbal assurances.
L. monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis, an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
It is essential to identify the areas of your facility where L monocytogenes is able to grow and survive (niche areas) and to take such corrective actions as necessary to control the organism. Adequate sanitation controls should include effective environmental monitoring programs designed to identify and eliminate and/or control pathogens such as L monocytogenes in and on surfaces and areas in the facility where contamination could result in food product contamination.
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 applicable statutes and regulations enforced by the FDA. You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to the Food and Drug Administration, Attention: Darlene B. Almogela, Compliance Branch Director, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have questions regarding any issue in this letter, please contact Russell Campbell, Compliance Officer, at (510) 331-6861.
Barbara J. Cassens
San Francisco District
U.S. Food and Drug Administration