WARNING LETTER

Holy Land Brand Inc. MARCS-CMS 552966 — June 29, 2018

Recipient:: Recipient Name

Majdi M. Wadi; Holy Land Brand Inc.; 2709 Broadway Street NE
Minneapolis, MN 55413-1736
United States

Issuing Office:: Minneapolis District Office; United States

Office of Human and Animal Foods - West Division 1
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
(612) 334-4100

June 29, 2018

WARNING LETTER

via UPS Overnight Delivery Refer to CMS 552966

Majdi M. Wadi

CEO/Owner

Holy Land Brand, Inc.

2709 Broadway Street NE

Minneapolis, Minnesota 55413-1736

Dear Mr. Wadi:

The U.S. Food and Drug Administration (FDA) inspected your food storage warehouse located at 2709 Broadway Street NE, Minneapolis, Minnesota, from February 2, 2018, through March 9, 2018. That inspection revealed serious violations of subpart B of the Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 (21 CFR 117) (CGMP & PC Rule). The violations include significant evidence of rodent activity and insanitary conditions throughout your facility. Additionally, during the inspection FDA collected three samples from your facility consisting of rodent excreta pellets, and pieces of a bag of rice with rodent nesting material and a rodent gnaw hole. FDA’s analysis of these samples confirmed the presence of rodents and rodent excreta pellets in your facility. Based on FDA’s analytical results for the samples and inspectional findings documented during the inspection, we have determined that your food products susceptible to rodent activity, including your bagged rice and bagged bean 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 have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

At the conclusion of the inspection FDA issued a FDA Form-483, Inspectional Observations, listing the violations found at your facility. We acknowledge your firm’s disposal of a 40-lb. bag of (b)(4) Brand Golden Sella Basmati Rice as a corrective action to FDA’s observation of rodent nesting material at the bottom layer of the pallet where the product was stored. We also acknowledge receipt of your correspondence on March 23, 2018, which outlined the corrective actions your firm has taken in response to the Form FDA-483, Inspectional Observations. These corrective actions are addressed further below.

During this inspection, FDA investigators observed the following significant violation of the CGMP requirements in subpart B:

You did not take effective measures to exclude pests from your packing and holding areas and to protect against contamination of food on the premises by pests, as required by 21 CFR 117.35(c). During the inspection FDA investigators noted evidence of rodent activity in the following food storage areas in your facility:

A rodent nest was observed on the bottom layer of a pallet of (b)(4) Brand Golden Sella Basmati Rice.
Rodent excreta pellets too-numerous-to-count were observed along all walls (north, south, east, and west) of the warehouse, under storage racks (aisle 3), on storage rack frames (north bays 1 and 2 in aisle 2), under the refrigerator, and in the electrical box room. Additionally, rodent excreta pellets were observed on pallets of white beans, rice, and lentils.
A rodent gnawed hole, approximately 1 inch x 1 inch, in a 40-lb. bag of (b)(4) Brand Golden State Basmati Rice and rodent excreta pellets were observed on the product of the same pallet.
Rodent excreta pellets, fluorescing stains, and gnawed material were observed on a pallet of canned broad beans after your firm conducted a deep cleaning.
Live rodents trapped in the live trap along the west wall and a rodent in the snap trap along the north wall of the warehouse were observed on multiple days.
Gaps were observed under the main door in the northwest corner of the warehouse, approximately ¼ inches x 8 inches, and around the I-beam going through the east walk into the adjoining building space that was greater than ¼ inch. These gaps are large enough for rodents to gain entrance to the warehouse.

We acknowledge your firm’s response dated March 23, 2018. However, we are unable to evaluate the adequacy of your corrective actions. Your response stated “that no rodent activity was reported by your pest control company.” However, activity was noted on multiple reports that our investigator reviewed, where the pest control company recommended immediate corrections. Our investigation revealed the corrections were not addressed. You also stated that you have terminated this pest control company who left the pest control reports at your facility and hired a new company that e-mails the reports to your management office. You stated that the report is reviewed by your firm’s management, who takes immediate corrective actions. Additionally, your response states that all holes and gaps mentioned in the FDA report have been closed. However, you have not provided evidence (i.e., pictures, invoices, or receipts) that corrective actions were taken. We will evaluate the adequacy of your corrective actions at our next inspection.

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 re-inspection-related costs. A re-inspection 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. 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

You should notify this office in writing within 15 working days of the receipt of this letter with 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. You should include documentation in your response, 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 Dianna C. Sonnenburg at the address above. If you have questions regarding any issues in this letter, please contact Ms. Sonnenburg at (612) 758-7125.

Sincerely,

/S/

Michael Dutcher, DVM

Director, West Division 1

Office of Human and Animal Food Operations