| Public Health Service Food and Drug Administration |
New Orleans District |
Department of Health and Human ServicesMay 25, 2011
WARNING LETTER NO. 2011-NOL-16
UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Dana Dykstra, President
Lumen Soy Foods, LLC
16142 Harbor View Drive
Spring Lake, Michigan 49456
Dear Mr. Dykstra:
On February 22-25, 28, March 3, 4, 7, 9, and 11, 2011, U.S. Food and Drug Administration (FDA) investigators inspected your soy protein meatless meat products processing facility, located at 409 Scott Street, Lake Charles, Louisiana. The inspection revealed serious violations of FDA’s Current Good Manufacturing Practice requirements in Manufacturing, Packing, or Holding Human Food, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). These conditions cause the food products held 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)] because they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. You may find the Act and its implementing regulations through links on FDA’s Internet homepage at www.fda.gov.
The significant violations were as follows:
1. Your firm failed to take effective measures 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). Specifically, our investigators observed the following:
• There was evidence of widespread rodent activity in, on, and near foods stored in your food processing facility, including the warehouse, packing room, and ingredient store room. For example:
o An inspection of fifty four 50 pound paper bags of textured vegetable protein, lot number 091026178, on February 23, 24, and 28, 2011, revealed two fresh appearing rodent excreta pellets under the plastic, five fresh appearing rodent excreta pellets, at least two apparent rodent hairs, and numerous fluorescing rodent urine stains on a bag located on the second layer of pallet number 2. There were six fresh appearing rodent excreta pellets; apparent rodent gnawed material; at least five apparent rodent hairs, and one large fluorescing rodent urine stain on a bag on the third layer of pallet number 2.
o One live rodent in a rat trap was observed on March 9, 2011, between two pallets of textured vegetable protein located in the warehouse approximately six feet east and six feet south of the west end of the north wall that is adjacent to the tool room.
o An inspection of two 50 pound bags of pepperoni seasoning in the packing room on February 24 and 25, 2011, revealed one bag had multiple fluorescing rodent urine stains.
o An inspection of three 44 pound bags of soy isolate in the packing room on February 24 and 25, 2011, revealed at least 20 rodent hairs and one fluorescing rodent urine stain.
o At least 14 fresh appearing rodent excreta pellets were observed on February 24 and 25, 2011, behind the pallet rack on the south wall of the packing room.
o Ten fresh appearing rodent excreta pellets and one dead roach were observed on February 25, 2011, behind a green tote containing carob flavor and beneath a packing table along the center of the south wall of the ingredient room.
FDA’s laboratory tests of samples taken from the warehouse, packing room, ingredient room, and a lot of textured vegetable protein confirmed the findings of rodent excreta pellets, rodent hair, and rodent urine stained and gnawed packaging throughout your facility.
2. Your firm failed to provide, where necessary, adequate screening or other protection against pests, as required by 21 CFR 110.20(b)(7). Specifically, our investigators observed the following:
• There was an approximately ½” x 5’ gap beneath the roll down door on the northwest wall of the warehouse extending from the west side to the center of the door leading outside of the facility. This door was approximately 10 feet from pallets of textured vegetable protein.
• There were two openings along the top of the roll down door on the northwest wall of the warehouse leading outside of the facility. The gap along the west end was approximately ¾” x 12” wide and the other gap was approximately 1 ½’x 2’ wide.
• There was an approximately 1” x 12” opening beneath the roll down door on the southwest wall of the warehouse leading outside of the facility and approximately 20 feet south of pallets of textured vegetable protein.
• There was a 1” x 1½’ opening beneath the roll down door on the southwest wall of the warehouse which leads directly outdoors.
• There were two unscreened vents in the ceiling of the warehouse which were approximately 10’ and 30’ from the east wall, respectively. The vent nearest the east wall was above a pallet containing 30 paper bags of textured vegetable protein, lot number 101251062.
• There was one 2” x 2” hole in the southeast corner of the warehouse which was approximately 18” from a pallet containing 30 brown paper bags of textured vegetable protein.
The above listed violations are not intended to be an all-inclusive list of deficiencies in your facility. It is your responsibility to ensure your facility is in compliance with applicable statutes enforced by FDA. Failure to promptly correct and prevent the recurrence of these violations may result in regulatory action without further notice, such as a seizure and/or injunction.
At the conclusion of the inspection, FDA investigators presented to Mr. Alex F. Cuevas, General Manager, a FORM FDA 483 (FDA 483), Inspectional Observations, dated March 11, 2011. We acknowledge your firm’s voluntary corrective actions taken in response to the insanitary conditions brought to your firm’s attention. We note, on March 4, 2011, your firm, under the supervision of Louisiana Department of Health and Hospitals (LDHH), voluntarily destroyed numerous containers of ingredients, packaging, and finished food products which had been seized by LDHH on February 22, 2011, and had been stored throughout your facility. We also acknowledge the written response to the FDA 483 of Mr. David Masciarelli, COO, dated March 15, 2011, stating all known potential points of entry were sealed. However, your firm’s response is inadequate because you did not include documentation of your corrective actions. The adequacy of the corrective actions submitted will be further assessed at our next inspection.
Please respond in writing within 15 working days of your receipt of this letter outlining the additional steps you have taken to bring your firm into compliance with the law, including steps taken to correct the violations and prevent their recurrence. You should include in your response documentation, such as written procedures, and other useful information to assist us in further evaluating your corrective actions. If corrective action cannot be completed within 15 working days, we expect you to explain the reason for the delay and state when the remaining violations will be corrected.
Please send your reply to the U. S. Food and Drug Administration, Attention: Mark W. Rivero, at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rivero at (504) 219-8818, extension 103.
Sincerely,
/s/
Philip S. Campbell
Acting District Director
New Orleans District
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