| Public Health Service Food and Drug Administration |
| Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996 |
Department of Health and Human Services
February 16, 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-12
Keith D. Bloxham, President and Owner
La Mexicana, Inc.
10020 14th Avenue Southwest
Seattle, Washington 98146
WARNING LETTER
Dear Mr. Bloxham:
The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 10022 16th Avenue Southwest, Seattle, Washington, on October 1, 2, 5, and 7, 2009. The inspection was conducted to determine your compliance with FDA's Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Our investigators documented serious deviations from the regulations that cause the 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or may have been rendered injurious to health. You may find the Act and associated regulations through links in FDA's Internet home page at http://www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional Observations, which delineated a number of CGMP deviations at your firm. The deviations include, but are not limited to, the following:
1. Persons who are shown to have, or appear to have, an illness, open lesion, including boils, sores, or infected wounds, or any other abnormal source of microbial contamination by which there is a reasonable possibility of food, food contact surfaces, or food-packaging materials becoming contaminated, must be excluded from any operations which may be expected to result in such contamination until the condition is corrected, to comply with 21 CFR 110.10(a). However, you failed to exclude one of your employees with an open lesion from such food handling operations. Our inspector observed an employee at the industrial dough mixer directly handling dough with a sore approximately half an inch in diameter on the employee's right forearm, including placing his right forearm into the bulk dough in direct contact with the sore on his arm.
2. All persons working in direct contact with food, food-contact surfaces, and food packaging materials must conform to hygienic practices while on duty to the extent necessary to protect against contamination of food, including washing hands thoroughly (and sanitizing if necessary to protect against contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the workstation, and at any other time when the hands may have become soiled or contaminated, to comply with 21 CFR 110.10(b)(3); maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary condition, to comply with CFR 110.10(b)(5); and taking any other necessary precautions to protect against contamination of food, food contact surfaces, or food-packaging materials with microorganisms or foreign substances including, but not limited to, perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied to the skin, to comply with CFR 110.10(b)(9).
However, your employees working in direct contact with food did not comply with the above requirements, as evidenced by the following observations:
• On October 1, 2009, an employee, directly handling dough, left the facility with his gloves, apron, and hairnet and returned with raw ingredients on a hand-truck. The employee immediately returned to the dough divider/roller and began handling the dough without washing and sanitizing his gloved hands or replacing his soiled gloves with clean gloves;
• On October 1, 2009, an employee, in the process of coating dough balls with flour, dipped both arms in a container of flour and directly contacted the flour with the length of her bare forearms;
• On October 2, 2009, six employees did not wash their hands after arriving for their shift. Employees also routinely left their stations to go outside to retrieve ingredients and returned to their stations without washing and sanitizing their hands;
• On October 2, 2009, two employees repeatedly stored gloves, used in production, in their back pocket while taking a break and reused these gloves when returning to their station, where they resumed food handling, without washing and sanitizing their gloved hands or replacing their soiled gloves with clean gloves;
• On October 2, 2009, an employee breathed into the gloves prior-to inserting her hands into the gloves and engaged in food handling without washing and sanitizing her gloved hands or replacing her soiled gloves with clean gloves;
• On October 2, 2009, an employee tied the gloves around the apron neck strap while on break and returned to food handling without washing and sanitizing her gloved hands or replacing her soiled gloves with clean gloves;
• On October 2, 2009, an employee wearing gloves during a break handled personal equipment and a beverage and returned to her work station, where she handled food without washing and sanitizing her gloved hands or replacing her soiled gloves with clean gloves; and
• On October 2, 2009, gloves were stored on the faucet of the hand washing sink.
3. All food manufacturing, including packaging and storage, must be conducted under such conditions and controls as are necessary to minimize the potential for the contamination of food, to comply with 21 CFR 110.80(b)(2), and work-in-process must be handled in a manner that protects against contamination, to comply with 21 CFR 110.80(b)(5). However, you failed to comply with the above requirements, as evidenced by the following observations:
• On October 1, 2009, tortillas on the cooling conveyer section of your (b)(4) tortilla machine were being manufactured directly beneath a vent duct that had an accumulation of flour residue and dust that was starting to flake.
• On October 1, 2009, an employee removed a sheet pan filled with scrap tortilla dough that had been sitting on a non-food contact surface area of the oven section on one of your tortilla machines. The non-food contact area had an accumulation of old residual flour and carbon on it. The employee then transferred the sheet pan to the scrap tortilla reworking tub and nested the bottom of the sheet pan directly on the dough that was going to be reworked. The employee then used the sheet pan to scoop up flour from an open bin, with the bottom of the sheet pan directly contacting the flour. Dark specks were left on the top of the dough in the scrap tortilla reworking tub where the tray had been nested.
• On October 2, 2009, tortillas on the conveyer belt exiting the oven section of your (b)(4) tortilla machine were being manufactured directly beneath a vent duct that had an accumulation of flour residue and dust that was starting to flake.
• On October 2, 2009, an employee allowed the dough in an industrial mixer to hang from the lip of the mixing bowl and come in direct contact with a grate on the front of the machine, a non-food contact surface, which had hard and discolored dough residue on it.
• On October 1, 2, and 5, 2009, two large fans that had an accumulation of dust and flour covering the fan cages, were observed blowing directly onto finished tortillas on all (b)(4) production lines. One of the fans was located under an open vent duct that had a build-up of flour and dust that was beginning to flake.
• On October 1, 2, and 5, 2009, an open pitcher of oil and dough softener tablets soaking in water were stored at the employee hand washing station directly below a wall area that was soiled and exhibited cracking and chipping. Also, an uncovered metal pot of oil was stored on a stool next to the hand washing station.
4. No pests shall be allowed in any area of a food plant and effective measures must be taken to exclude pests, including rodents, from the processing areas and to protect against the contamination of food on the premises by pests, to comply with 21 CFR 110.35(c). However, you failed to comply with the above requirements, as evidenced by the following:
• On October 1, 2009, a package of tortillas was observed behind a table used for boxing the packaged finished product, directly behind the first tortilla machine packing area. The tortilla package had three apparent gnaw holes in the bag, and the tortillas inside the bag were stiff and covered with spots of apparent mold.
• On October 1, 2009, four apparent rodent excreta pellets were observed in the packaging area of your production facility. Two were located approximately five feet from the bay door on the east wall. One was located against the same wall at the northeast corner of the facility. One was found directly behind the first tortilla machine packing area, against the wall.
• On October 2, 2009, three apparent rodent excreta pellets were observed in the packaging area of your production facility. These were observed after the area was reported to have been cleaned and the apparent rodent excreta pellets noted on the previous day had been removed. Two were located approximately five feet from the bay door on the east wall. One was found directly behind the first tortilla machine packing area, against the wall beside a table used for boxing the packaged finished product.
• On October 2,2009, evidence of pest activity was observed in your raw ingredient storage warehouse, including:
• An apparent rodent nest made from the exposed insulation from the wall in the southwest corner of the building;
• At least 23 apparent rodent excreta pellets in the same location as the apparent rodent nest, and at least 16 apparent rodent excreta pellets located five feet east along the south wall of your raw ingredient storage warehouse;
• Thirteen apparent rodent excreta pellets along the west wall of your raw ingredient storage warehouse. Ten were located on the second shelf of a storage rack behind several boxes of tortilla packaging bags. Three were located approximately ten feet north on the west wall on the floor under a storage rack. An eight inch long bird feather was lying on the floor in the same vicinity.
• At least 21 apparent rodent excreta pellets directly underneath a pallet of Press Batch (dough ingredient mix), approximately 12 feet from both the east-most and north-most walls of your raw ingredient storage warehouse.
• On October 5, 2009, at least four apparent rodent excreta pellets were observed south of the south most bay door in your raw ingredient storage warehouse. Also at least four apparent rodent excreta pellets were observed under a pallet on the second shelf of a storage rack on the west wall.
5. All food-contact surfaces, including utensils and food-contact surfaces of equipment, shall be cleaned as frequently as necessary to protect against contamination of food, to comply with 21 CFR 110.35(d). However, you failed to comply with the above requirements, as evidenced by the following observations:
• Circular blades you use to cut the tortillas into the desired shape were stored on a piece of cardboard with flour residue built up on the surface.
• The knife, which is used for cutting the dough when removing it from your industrial mixer, had hardened dough residue on its contact surface and was stored between uses in direct contact with the mixer's side-wall which was soiled with hardened dough and food residue.
• The contact surfaces of the dough scrapers used at both dough mixing stations had hardened food residues and were stored between used non-food contact surfaces of the mixer, which were soiled with residual flour and hardened dough.
• After equipment clean-up and prior to production on October 2, 2009 (b)(4) of the (b)(4) tortilla machines had an accumulation of flour residue on the dough ball vertical conveyors, the flattening conveyors, and on the inside of the machine where the tortilla is flattened and is routed prior to coming out of the machine and into the oven.
• After equipment clean-up and prior to production on October 2, 2009 (b)(4) If the (b)(4) dough divider/rounders had dough residue on the inside of the bowl.
6. You must provide your plant or facility, where necessary, adequate screening or other protection against pests, to comply with 21 CFR 110.20(b)(7). However, you failed to comply with the above requirements, as evidenced by the following observations:
• On October 1, 2, and 5, 2009, the large bay door in the tortilla packaging area was open approximately three feet with no screening to the outside, approximately ten feet from the garbage dumpsters.
• On October 1, 2, and 5, 2009, the front screen door, which opens to the outside from your tortilla production area, was left open by employees exiting the building.
• The outside screened bay door of your tortilla production area was torn in multiple places. The screen itself had an approximate two inch gap between the screen and the frame of the bay door.
• The south-most bay door of your raw ingredient storage warehouse had a 17"x 50"x 10" gap to the outside at its top exterior right corner.
This letter is not intended to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure that your facility is in compliance with the Act and the CGMP regulations. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
You should take prompt action to correct all of the violations noted in this letter. Failure to promptly correct these violations may result in legal action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these deviations. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and state when you will correct any remaining deviations.
Please send your reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Michael J. Donovan, Compliance Officer, at (425) 483-4906.
Sincerely,
/S/
Charles M. Breen
District Director
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