Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/amj-distribution-company-06072016
Timestamp: 2020-03-31 20:03:12
Document Index: 339300335

Matched Legal Cases: ['art 110', '§ 342', 'art 123', 'art 123', '§ 342', '§ 379', '§ 379']

AMJ Distribution Company - 06/07/2016 | FDA
AMJ Distribution Company - 06/07/2016
AMJ Distribution Company June 07, 2016
AMJ Distribution Company
Refer to MIN 16 - 12
Anne Marie A. Johnson
AMJ Distribution Company, Inc.
6317 Welcome Avenue North, Suite 13
Brooklyn Park, Minnesota 55429-2017
The Food and Drug Administration (FDA) conducted an inspection of AMJ Distribution Company, Inc. located at 6317 Welcome Avenue North Suites 12 and 13, Brooklyn Park, Minnesota, from March 24 to April 13, 2016. Our inspection found your firm is a warehouse and distributor of multiple food products including, but not limited to, corn, millet, Egussi seeds, and ready-to-eat dried/smoked seafood products.
The inspection revealed serious violations of Title 21 of the Code of Federal Regulations (21 CFR) Part 110 - Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulation. The violations included significant evidence of rodent activity and insanitary conditions throughout your facility. During this inspection the following four samples were collected that documented rodent and insect evidence throughout the facility: sample INV930841 demonstrates the presence of rodent excreta pellets and rodent hair; sample 930842, Egussi seeds, demonstrates the presence of rodent gnawing, rodent hair, rodent urine, rodent excreta pellets and the adult head of a Oryzaephilus surinamensis (sawtoothed grain beetle); sample 952285, millet, reveals gnaw holes in product packaging and 18 dead adult Oryzaephilus surinamensis (sawtoothed grain beetle); sample 952286 reveals the presence of 1 dead adult Oryzaephilus mercator (merchant grain beetle), 8 dead adult Oryzaephilus surinamensis (sawtoothed grain beetle), 26 dead Oryzaephilus sp. pupae/pre-pupae, 10 dead Oryzaephilus sp. Larvae, and 7 dead adult Chalcid wasps. The presence of multi-stage Oryzaephilus sp. beetles indicates an ongoing infestation.
Because the food products you warehouse and distribute have been prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health, your food products are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). You can find the Act and FDA’s regulations through links on FDA’s home page at www.fda.gov.
A. On March 23 and 24, 2016, rodent excreta pellets too numerous to count were observed on surfaces and in boxes of product throughout the warehouse, including:
(1) Rodent excreta pellets too numerous to count observed on the lid and 2 cardboard boxes stacked on a large cardboard tote containing synthetic poly-woven bags of Bissap.
(2) More than 100 rodent excreta pellets were observed on top of a case labeled “Bassi Sucre.”
(3) Rodent excreta pellets were observed on the surfaces of rigid plastic containers on a mixed pallet of cooking oil containers.
B. On March 25, 2016, in a large cardboard tote containing Egussi Seeds, gnaw holes were observed on two bags. Rodent excreta pellets were observed within the product directly under the gnaw hole, and stains fluorescing bright yellow under ultraviolet light (which is consistent with rodent urine) were observed on the surface of bags and exposed seeds.
C. On March 30, 2016, a mixed pallet of millet, corn grits and tea stored in the ambient warehouse was observed with rodent excreta pellets, live and dead beetle-like insects, and stains fluorescing bright yellow under ultraviolet light (which is consistent with rodent urine).
2. Failure to store and dispose of rubbish to minimize the potential for waste becoming an attractant and harborage or breeding place for pests, as required by 21 CFR 110.37(f). Specifically, our investigators observed:
A. Empty boxes, empty containers, and plastic product totes filled with other empty totes and plastic bags.
B. A small, unplugged refrigerator with full containers of soy milk inside.
C. A trash bag with apparent mold and rotting rubbish inside.
D. Piles and bags of non-food items piled in and around stored product to include, but not limited to, old clothing, paint rollers, a picnic-type cooler, and window blinds.
3. Failure to maintain buildings and fixtures in repair sufficient to prevent food from becoming adulterated within the meaning of the Act, to comply with 21 CFR 110.35(a). Specifically, our investigators observed gaps measuring approximately 1 x 4 inches on the bottom corners of the dock door.
We also found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). Accordingly, your ready-to-eat dried/smoked seafood products are adulterated in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links on FDA’s home page at www.fda.gov.
1. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for your ready-to-eat smoked/dried pike and catfish, dried boney fish, snails, and fish powder to control food safety hazards which may include allergens, pathogen growth, and toxin formation, e.g. Staphylococcus aureus.
2. You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2). However, your firm imports a variety of ready-to-eat seafood products including, but not limited to, smoked/dried pike, smoked catfish, dried boney fish, snails, and fish powder, and you do not have product specifications to address hazards such as histamine, environmental chemicals, aquaculture drugs, potential metal inclusion, undeclared food allergens/food additives, and pathogen growth or potential toxin formation including, for example, Staphylococcus aureus toxin formation.
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).
Please respond to this office in writing within 15 working days from your receipt of this letter. In your response, identify the procedures you have taken or will take to completely correct the current violations and prevent similar ones. In your response please include the timeframe in which the corrections will be completed and provide documentation that will effectively assist us in evaluating whether the corrections have been made and their adequacy. If you are unable to complete the corrective actions within 15 working days, identify the reason for the delay and the time within which you will complete the correction(s).
Please send your reply to the Food and Drug Administration, Attention: Dianna C. Sonnenburg, Compliance Officer, at the address listed in the heading of this letter. If you have questions regarding any issue in this letter, please contact Ms. Sonnenburg at (612) 758-7125.