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  5. Ruben's Inc. - 568410 - 11/06/2018
  1. Warning Letters

WARNING LETTER

Ruben's Inc. MARCS-CMS 568410 —


Delivery Method:
UPS Overnight
Reference #:
HAF4W-19-02-WL-DR
Product:
Food & Beverages
Prepared Food

Recipient:
Recipient Name
Mr. David Garcia
Recipient Title
President
Ruben's Inc.

401 Maple St. SE

Albuquerque, NM 87106
United States

Issuing Office:
Center for Food Safety and Applied Nutrition

6th Ave & Kipling St, Bldg 20, DFC
P.O. Box 25087
Denver, CO 80225
United States


Dear Mr. Garcia:

From September 11-12, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your manufacturing facility located at 401 Maple Street, SE, Albuquerque, New Mexico.  Based on the inspectional findings we have identified serious violations of the Current Good Manufacturing Practices (CGMP), in Manufacturing, Packing, or Holding Human Foods regulation (Title 21, Code of Federal Regulations, Part 110). Accordingly, we have determined the foods manufactured and stored at 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 the products were prepared, packed, or held under insanitary conditions whereby the may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act and FDA regulations through links on FDA’s website at www.fda.gov.

Specifically, our inspection of your facility revealed the following cGMP violations:

1.    Buildings and Facilities: Sanitary Operations (21 CFR 110.35)

a.  Effective measures are not being taken to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 110.35(c). For example, live and dead apparent cockroaches, spiders, ants, and bugs, in various stages of lifecycle were observed in the receiving, processing, dry storage, restrooms and office areas. Additionally, pests were observed crawling across floors, up walls, in and out of crevices in the walls and floors, on the ceiling, trapped in mailing tape near light switches, at the handwashing station, on food contact surfaces, on a conveyor belt, and on the ceiling directly above the (b)(4) grinder and (b)(4) fryer. Apparent rodent like droppings were also observed in the corners of the dry storage area.         

This was a repeat observation from the inspections in 2016 and 2005.

b.  You failed to clean food-contact surfaces as frequently as necessary to protect against contamination of food as required by 21 CFR 110.35(d). Specifically, the (b)(4) grinder had red chile paste leftover from the last production run between the (b)(4), and the (b)(4) had an accumulation of red chile flakes located near the front of the equipment.

c.  You failed to maintain physical facilities in repair sufficient to prevent food from becoming adulterated as required by 21 CFR 110.35(a). The ceiling in the walk-in freezer, which holds prepared foods including chile rellenos and other ingredients, as well as the processing area are not maintained in sufficient repair. For example:

  • Wall tiles are missing, and paint is flaking off the pipes and walls in the processing area.
  • The condensation unit in the walk-in freezer storage area was leaking and an accumulation of ice build-up was observed on the floor directly adjacent to the finished red chile product.
  • Several tiles were missing on the production floor. Water was pooling on the floor where tiles were missing/broken.
  • (b)(4) hand washing sink is in production area, which leaked water onto the floor when turned on. The direct surrounding areas such as floor, wall, paper towel dispenser and soap dispenser handles were dirty. Additionally, the floor had a build-up of thick grime near foot pedals.
  • An accumulation of black debris and grime on support poles, light switches and plastic curtains was observed between rooms and the walk-in refrigerator.
  • Lights directly over the chile peeling area were not working and there were ceiling tiles missing directly adjacent to non-functioning lights. 

This was a repeat observation from the inspections in 2016, 2009, and 2005.

2.    Buildings and Facilities: Plant and Grounds (21 CFR 110.20)

a.  You failed to properly maintain the facility driveway so that it does not constitute a source of contamination in areas where food is exposed as required by 21 CFR 110.20(a)(2). For example, a large pool of standing water was observed in the receiving area next to (b)(4) bags of white corn.

3.    Buildings and Facilities: Sanitary Facilities and Grounds (21 CFR 110.37)

a.  You failed to adequately equip your facility with plumbing of adequate size and design and installed and maintained to avoid constituting a source of contamination to food as required by 21 CFR 110.37(b)(3). For example, during the chile relleno cooling process, the tank is (b)(4) and (b)(4) times with (b)(4) from a nonfood grade black hose. Throughout the process the end of the hose was placed directly onto the dirty floor multiple times presenting a potential source for product cross-contamination.

b.  You failed to maintain toilet facilities in a sanitary condition as required by 21 CFR 110.37(d)(1). For example, dead bugs were observed in the women’s restroom, which also did not contain toilet paper on 9/11/18. Additionally, we observed a strong urine odor in the men’s restroom which also contained a dirty and discolored sink.

This was a repeat observation from the inspection in 2009.

4.    Production and Process Controls: Processes and Controls (21 CFR 110.80)

a.  You failed to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms and contamination, as required by 21 CFR 110.80(b)(2). For example:

  • Employees touched the outside of large nonfood grade white (b)(4) trash cans covered in a black mold type debris which contained rinsed/cooled chiles. The employees then peeled the chiles without washing their hands after touching the black mold type debris.
  • Chiles fell onto the dirty floor and were picked up by employees and placed into the rinse/cooling tank with other roasted chiles.
  • Uncovered chile relleno products were observed in the walk-in freezer. The ceiling directly above the uncovered products displayed an accumulation of condensation drops and peeling paint.
  • Uncovered masa product was observed in the walk-in refrigerator. We observed a strong moldy type odor in the walk-in refrigerator near a puddle of white liquid on the floor
  • We observed an employee push an uncovered rack of green chile from the walk-in refrigerator into the production area. The sides and top layer of green chile came in direct contact with an (b)(4) curtain which appeared to be soiled with red chile debris and grime. 

This was a repeat observation from the inspection in 2016 and 2009.

b.  You failed to maintain equipment, containers and utensils used to convey and hold food in a manner that protects against contamination as required by 21 CFR 110.80(b)(7). For example, we observed clear mailing tape used to secure a (b)(4) funnel to a dirty handle. This is used to convey the posole into the final packaging bags.

To date, we have not received a written response from you. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of the Act and implementing regulations. 

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure, injunction or prosecution.

Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs.

Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent these violations or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. If your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Kathleen S. Tormey, Compliance Officer; P.O. Box 25087, Denver, Colorado, 80225-0087. You may reach Ms. Tormey at (303) 236-3137 or via email at Kathleen.tormey@fda.hhs.gov if you have any questions about this matter.

 

Sincerely,

/S/ 

LaTonya M. Mitchell

Program Division Director

Office of Human and Animal Foods –

Division IV West