Gold Star Distrbution., Inc. - 562931 - 10/19/2018

October 19, 2018

WARNING LETTER

Via UPS Overnight Delivery                                                        Refer to CMS 562931

Bassam Abu Samrah
Owner
Gold Star Distribution, Inc.
1000 Humboldt Avenue North
Minneapolis, Minnesota 55411-3964

Dear Mr. Abu Samrah:

The U.S. Food and Drug Administration (FDA) inspected your food storage warehouse located at 1000 Humboldt Avenue North, Minneapolis, Minnesota, from July 12-July 20, 2018. The inspection revealed serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule (CGMP & PC rule) at Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). The violations include significant evidence of rodent activity and insanitary conditions throughout your facility.

During the inspection FDA collected physical sample #INV1032309 from your facility, which consisted of five (5) subsamples (each referred to as a sub). Our laboratory’s analysis confirmed that the subsamples consisted of mouse excreta pellets (subs 1, 3, 4, and 5) and rat/mouse hairs (subs 1, 2, 3, 4, and 5). The analytical results for this sample confirm the presence of rodent activity within your facility. Based on FDA’s analytical results for sample #INV1032309 and inspectional findings documented during the inspection, we have determined that your food products are 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. You may find the Act through the links on FDA’s home page at www.fda.gov.

We note the following significant deviations:

1.    You did not take effective measures to exclude pests from your packing and holding areas to protect against contamination of food on the premises by pests, as required by 21 CFR 117.35(c). Specifically, during the inspection FDA investigators noted evidence of rodent activity in the following food storage areas in your facility:
A.   “Location 1”:
i.    More than 20 apparent rodent excreta pellets (referred to as REPs) were observed on a pallet of non-food product, along the east wall.
ii.    Apparent fecal matter from a small animal was observed behind pallets of various assorted prepacked candies, along the west wall.
iii.    A case of Burnt Peanuts appeared to be gnawed open, with fragments of the candies observed on the outside of several boxes on the pallet stored along the west wall.
B.   Center Storage area:
i.    Apparent REPs, too numerous to count, were observed on a pallet storing cases of elbow macaroni noodles in the Staging Location east of the Box/Packaging room.
ii.    More than five apparent REPs were observed on a plastic wrapped box of powdered drink mix stored along the south wall in the Staging Location.
C.   Small Volume Room:
i.    Apparent REPs, too numerous to count, were observed on a pallet of bottled hot sauce and bottled drinks. The hot sauce labels and cases appeared to be heavily gnawed, and apparent rodent nesting material was observed in the cases between the bottles. Fluorescing stains were observed on the bottles of hot sauce. Subs 1 and 3 of physical sample #INV1032309, which consisted of at least 10 REPs collected from this pallet between the bottles of hot sauce, were confirmed by our laboratory to be mouse excreta pellets.
ii.    Apparent gnaw holes were observed on two pallets of dry dog and cat foods packaged in paper bags; three bags were noted to be in various stages of fullness, from slightly to completely empty. Apparent REPs, too numerous to count, ¼ to 1 cm in length, and a dead rodent were also observed on the pallets. Sub 2 of physical sample #INV1032309, which consisted of hairs found on a bag of cat food, was confirmed by our laboratory to be rat/mouse hairs.
iii.    More than 10 apparent REPs were observed in a case of pasta sauce stored along the north wall. Spilled rice was also observed among the jars and several of the labels appeared gnawed. Sub 4 of physical sample #INV1032309, which consisted of apparent REPs collected between jars of the pasta sauce, were confirmed by our laboratory to be mouse excreta pellets.
D.   “Location 2”:
i.    At least two live birds were observed flying in various areas of the warehouse on the north and south ends. An apparent birds’ nest was observed in the center delivery dock door that was open on the south end.
ii.    More than five apparent small animal fecal droppings were observed behind pallets of various food products along the length of Storage Area A, along the west wall of the room.
iii.    A dead bird was observed under a pallet of pasta noodles being stored along a wall in the southwest corner of the room. Behind the pallet, a hole in the wall greater than 6 inches in length was observed to contain a dead rodent, and apparent REPs, too numerous to count, were observed along the wall.
iv.    Ten apparent REPs were observed on a case of boxed crackers that was stored on a pallet of miscellaneous returned food items. The pallet was in the center aisle area between Storage Areas A and B.
v.    More than six apparent REPs approximately 1 cm in length were observed in a track (approximately 1” in depth) in the floor that runs under pallets of various food products between Storage Racks E and F.
vi.    Apparent gnaw marks were observed on several packages of beef flavor instant ramen noodle meals stored on pallets on the floor between Storage Racks E and F. Sub 5 of physical sample #INV1032309, which consisted of apparent REPs collected from the freezer trough under the ramen, were confirmed by our laboratory to be mouse excreta pellets.
vii.    One apparent gnaw hole, spilled rice, and apparent REPs, too numerous to count, were observed on two pallets of bulk bagged rice stored in Aisle H.
viii.    Several live apparent fruit flies were observed inside packages of Dates on pallets located in the center of Storage Racks I and J. The insects, in quantities too numerous to count, were observed flying around the area.
ix.    Three dead rodents were observed on a pallet of cases containing bottles of maple syrup. Fluorescing stains, apparent REPs too numerous to count, apparent gnaw holes, and apparent nesting material were observed on and between the cases. The product was stored in Area J.
x.    Apparent REPs, too numerous to count, apparent gnaw holes, and apparent nesting material, were observed in and around boxes storing rolls of HDPE plastic bags, typically used in retail facilities for produce items. Also on the pallet were cases containing boxes of cereal. The product was stored in Area K.
xi.    More than 10 apparent REPs were observed on an outer plastic sleeve, on a case of canned iced tea, stored in area O.
xii.    Two dead rodents, in varying stages of decomposition, were observed along the east wall, behind Storage Rack R.
E.   Second Floor:
i.    Apparent REPs, too numerous to count, were observed near the center and close to the south wall where ramen noodles and iced tea were stored.
ii.    A dead mouse was observed on the floor along the east wall in the electrical room in the Center storage area. Apparent REPs, too numerous to count, were observed throughout the room, as well as two apparent bird feathers.

2.    You did not maintain your building, fixtures, and other physical facilities of your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, FDA investigators observed the following conditions:
A.   The roof appeared to be leaking in several areas of the facility including Location 1, Center Storage, and Location 2. Water was leaking onto several pallets of food items, including:
i.    A pallet of sugar, packaged in paper bags; the bags appeared wet and condensate was observed on the pallet wrapping.
ii.    Two pallets of freezies, packaged in cardboard boxes.
iii.    At least three pallets of bottled beverages throughout Location 2.
iv.    A pallet of Infant Formula being stored in the Center Storage room.
B.   Product spills were observed on the floor thoughout Location 2 and the Center Storage area, including canned and bottled beverages, pickles, ramen noodles, rice, and olives. The spills appeared as if they had been there for many days/weeks due to the decomposed appearance of the contents.

3.    You did not store food under conditions that protect against biological, chemical, and physical contamination, as well as against deterioration of the food and the container, as required by 21 CFR 117.93. Specifically,
i.    Bottles of bleach were leaking onto a pallet of hot sauce crunchy cheese curls being stored in aisle M. Apparent burn holes were observed on the boxes of cheese curls where the bleach had been dripping onto them.
ii.    A case of snack food was observed stored on top of several bottles of car motor oil stored in the Center Storage area.
iii.    Motor oil was observed being stored on top of and spilling onto a variety of bottled beverages in the northeast corner of Location 2.
iv.    A pallet of Cream Cheese with a label that indicated “Keep Refrigerated” was observed along the southeast wall in an unrefrigerated area.

4.    You failed to properly store equipment, remove litter and waste, and cut weeds and grass that may constitute an attractant, breeding place, or harborage for pests within the immediate vicinity of the plant, as required by 117.20(a)(1). Specifically,
i.    Over 20 pallets of various bottled beverages, stacks of wood and plastic pallets, unused equipment, several pallets of firewood, and stacks of black garbage bags full of leaves, approximately 2 feet high, were stored outside your facility along the southeast side of the building.
ii.    The vegetation along the eastern side of the property was overgrown and not maintained.
iii.    Trash buildup, approximately 1 foot high, was observed under the dock doors.

We acknowledge your firm’s voluntary destruction of the (b)(4) pallets embargoed by MDA as well as your voluntary destruction of several other pallets of potentially adulterated products as a corrective action to FDA’s observations of apparent rodent activity. We also acknowledge receipt of your correspondence dated July 19, 2018, entitled “Corrective Action Plan,” which outlined the corrective actions to which you committed, including: contract with a pest control service, repair the roof, hire a janitor, clean up pest harborage sites, keep dock doors closed, properly store chemicals, conduct monthly employee training, conduct internal audits, correct violative conditions, and keep records for roofing, sanitation, employee training, and pest control. However, your “Corrective Action Plan” failed to provide any documentation of the corrections (e.g., work orders, pictures, records, and training documents) or any timelines of when corrections would be made. FDA will evaluate the adequacy of your promised corrective actions during our next inspection of your facility.

(b)(3)(A)

This letter is not intended to be an all-inclusive list of violations at your facility or in connection with your products. You are responsible for ensuring that your facility operates in compliance with the Act, including the CGMP & PC rule. You should take prompt action to correct the violations noted in this letter. Failure to do so may result in regulatory action by the FDA without further notice, including seizure and/or injunction.

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

Please notify this office in writing within 15 working days of the receipt of this letter of the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. In your response you should include documentation, including photographs or other useful information that would assist us in evaluating your corrections. If you do not believe that your products are in violation of the Act, include your reasoning and any supporting information for our consideration. If the corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your written response to Compliance Officer Demetria Lueneburg at the address above. If you have questions regarding any issues in this letter, please contact Ms. Lueneburg at (612) 758-7210.

Sincerely,
/S/
Michael Dutcher, DVM
Director, West Division 1