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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Las Botanas

   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-4415

WARNING LETTER


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


June 18, 2009

 

W/L 21-09

Lizandro Jimenez, Owner
Dora Jimenez, Owner
Las Botanas
14555 Keswick Street
Van Nuys, CA 91405


Dear Mr. and Ms. Jimenez:


Starting on March 18, 2009 and ending on March 31, 2009, the Food and Drug Administration (FDA) inspected your food manufacturing firm located at 14555 Keswick Street, Van Nuys, CA. Our investigators documented significant violations of FDA's Current Good Manufacturing
Practice (CGMP) requirements for manufacturing, packing, or holding human food, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110) at your facility. Those violations cause the food products manufactured 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 rendered injurious to health. Furthermore, we also determined that your firm has failed to register with the FDA as required under section 415 of the Act [21 U.S.C.350d] and FDA's implementing regulation at 21 CFR Part 1, Subpart H [21 CFR 1.225 - 1.243]. You can find links to the Act and regulations at FDA's website at www.fda.gov.


Our inspection of your facility revealed the following violations of the CGMP regulation (21 CFR 110):


1. Failure to handle and maintain equipment, containers and utensils used to convey, hold, and store food in a manner that protects against contamination [21 CFR 110.80(b)(7)].


The inspector observed your employees sliding plastic rectangular transfer totes along the processing room concrete floor and then stacking the totes nested inside each other. The employees then unnested the totes and filled them with freshly fried whole beans (fava/lima) without cleaning or sanitizing the totes. The transfer totes were reused repeatedly throughout the day without cleaning and/or sanitizing.

 

2. Effective measures are not being taken to protect against the contamination of food on the
premises by pests [21 CFR 110.35(c)].


Specifically, rodent excreta were observed on burlap bags containing Spanish peanuts stored in the ingredient warehouse. Bags of peanuts, beans, and flour (raw ingredients), uncovered spice storage drums, and an uncovered electric blending mixer containing chili spices were observed stored in this ingredient warehouse. These products were near an open and unattended door leading directly into the firm's rear parking. Additionally, uncovered and unprotected finished products (i.e., fried whole peanuts, fried whole beans, and fried corn chips) cooling in bulk bins were observed stored approximately 15 feet from an open door leading directly into the rear parking lot.


3. Failure to take effective measures to protect finished food from contamination by other ingredients [21 CFR 110.80(b)(6)].


Specifically, bulk totes of uncovered l1'ied whole peanuts were observed sitting next to and contacting bulk totes of uncovered fried whole beans and fried corn chips. This could lead to cross-contamination of your products with allergens (i.e., foods not formulated to contain allergenic ingredients might contain undisclosed allergens).


4. Failure to clean and sanitize food-contact surfaces, utensils and equipment as frequently as necessary to protect against contamination of food [21 CFR 11 0.35(d)].


Specifically, transfer totes, bulk storage totes, and a chili coating tumbler used in transferring, holding, and coating peanuts with chili spices, respectively, were observed being used without cleaning and sanitizing prior to reuse in the production of corn chips and beans. This could lead to cross-contamination of your products with allergens (i.e., foods not formulated to contain allergenic ingredients might contain undisclosed allergens).


5. Employees did not maintain gloves used in food handling in an intact, clean, and sanitary condition [21 CFR 110.10(b)(5)] and did not wash and sanitize hands thoroughly in an adequate hand-washing facility after each absence from the work station and at any time
their hands may have become soiled or contaminated [21 CFR 110.10(b)(3)].


Specifically, on several occasions over two days, two employees were observed handling finished product with soiled gloves. These same gloves had been worn while these particular employees were away from their workstations/processing room handling the bottom of totes and buckets sitting on the floor. These same employees were also repeatedly observed touching the soiled plastic strip curtain that divides the middle processing room from the rear processing room with their bare hands and/or gloves and then returning to their workstations where they touched food with their bare hands and/or the same gloves. The employees did not wash or sanitize their hands or replace their
gloves before returning to their workstations.


6. Cleaning utensils and equipment is not conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials [21 CFR 110.35(a)].


Specifically, an employee was observed cleaning scoops by only rinsing the items with water without washing or sanitizing them. Finished product totes sitting on the floor and nested were only sanitized with steam once a week and not washed and sanitized daily after use or when they became dirty, soiled, unsanitary or contaminated. The facility lacked an adequate sink or other means for sanitizing cleaned utensils. Bulk storage totes used to store finished product while cooling were covered with an accumulation of oils, dirt and food residue.


7. Buildings, fixtures, and other physical facilities of the plan are not maintained in a sanitary condition and in repair sufficient to prevent food from becoming adulterated within the meaning of the Act [21 CFR 110.35(a)].


Specifically,


a) Uncovered fried corn chips (finished product) were observed sitting directly below an overhead exhaust fan that was covered with dust, grime, and debris.


b) Uncovered fried whole peanuts (finished product) were observed sitting directly below an overhead exhaust fan that was vented directly to the outside without any grid or protection from the outside elements or vermin. We note that the cover installed by your firm during the inspection was insufficient in that it lacked side protection covers to prohibit the entry of birds or vermin.


8. Failure to wear hair nets, caps, and hair restraints where appropriate [21 CFR 110.10(b)(6)].


Specifically, on 3/18/09, three employees were observed leaning over and/or packaging exposed finished product jelly candies, peanuts, and beans) without any hair covering or hair restraints such as bonnets or caps.


9. Suitable outer garments that protect against contamination of food are not worn [21 CFR 110.10(b)(1)].


Specifically, the firm's employees wore personal street clothing. Employee personal clothing was observed coming into direct contact with in-process and finished food. Additionally observed was the employees' street clothing coming in contact with unclean, dirty, grimy and greasy surfaces before the same clothing was observed to touch unprotected finished and in-process foods.


10. Failure to provide safety-type light bulbs and/or lighting fixtures suspended over exposed food or to otherwise protect against food contamination in case of glass breakage [21 CFR 110.20(b)(5)].


Specifically, glass fluorescent light bulbs hanging directly over in-process and finished product did not have protective covers, nor was any other protective measure taken in case of glass breakage.


11. Your plumbing is not adequately installed and maintained to avoid constituting a source of contamination to food, water supplies, equipment or utensils and/or creating an unsanitary condition [21 CFR 110.37(b)(3)] and lacks backflow protection between piping systems that discharge waste water or sewage and piping systems that carry water for food or food manufacturing [21 CFR 110.37(b)(5)].


Specifically, at least two water hoses that did not have backflow prevention were observed lying on the processing room floor. At least one of the above hoses was then used to fill up a large trough type tank with water that was being used to soak whole beans. This creates an unsanitary condition that could contaminate the tank of beans with material from the floor. Moreover, backflow, the reversal of the normal flow of potable water, can be dangerous if contaminated water is back-siphoned into a potable water source.


12. Employees failed to remove unsecured jewelry or other objects which might fall into food, equipment, or containers [21 CFR 110.10(b)(4)].


Specifically, one employee with uncovered dangling earrings was observed packaging jelly candy worms into plastic bags.


(b)(3)(B)

(b)(3)(B)


This letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing systems. You should investigate and determine the causes of the violations and take prompt actions to correct the violations to bring your products into compliance. Failure to promptly correct these violations may result in legal action without further notice including seizure and 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 action 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.


During the inspection, we also collected sample labels for some of your products. Our review of your sample labels revealed that you are not labeling your food products with nutritional information. We note that you may be eligible for a Small Business Nutrition Labeling Exemption with respect to your products [21 CFR 101.9(j)(18)]. Please be advised that, if you have fewer than 10 full time equivalent employees, you do not have to file for this exemption with respect to any food product with annual sales of less than 10,000 units; otherwise, you are
required to either provide nutrition information labeling on the product to comply with section 403(q)(1) of the Act and 21 CFR 101.9, or file for the exemption, if applicable. You can find more information about the Small Business Nutrition Labeling Exemption on FDA's web site at;
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/

GuidanceDocuments/FoodLabelingNutrition/ucm053857.htm


The product labels we reviewed bear information in both Spanish and English, but not all information required to be on the label appears in both languages. However, in accordance with 21 CFR 101.15(c)(2), because the products' labels contain some information in both Spanish and English, all of the required label information must appear in both Spanish and English.


Your response should be sent to:


Dennis Farley
Acting Director, Compliance Branch
United States Food and Drug Administration
19701 Fairchild
Irvine, CA 92612-2506


If you have any questions about the content of this letter please contact John J. Stamp, Compliance Officer, at 949-608-4464.

 

Sincerely,

/S/
Alonza E. Cruse
District Director


cc: Jeff Farrar, DVM, PhD, MPH
Branch Chief
Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue-MS 7602
P.O. Box 997413
Sacramento, CA 95899-7413