WARNING LETTER

LNZRO Pizza Empire, Inc. MARCS-CMS 556401 — June 11, 2018

Recipient:: Recipient Name

Mr. George R. Musak; LNZRO Pizza Empire, Inc.; 4278 Fay Road
Syracuse, NY 13219
United States

Issuing Office:: New York District Office; United States

WARNING LETTER

CMS# 556401

UNITED PARCEL SERVICE

SIGNATURE REQUIRED

June 11, 2018

Mr. George R. Musak, President

LNZRO Pizza Empire, Inc.

4278 Fay Road

Syracuse, NY 13219

Dear Mr. Musak:

We inspected your seafood processing and distribution facility located at 4278 Fay Road, Syracuse NY 13219 on May 10, 2018 and May 18, 2018. We found you have serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations(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 Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your refrigerated, ready-to-eat canned crab meat and battered/breaded haddock is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 in FDA's Internet home page at www.fda.gov.

We acknowledge receipt of your electronic response letter dated June 1, 2018 responding to the Form FDA-483, Inspection Observations (FDA-483), issued to you on May 18, 2018. We address the adequacy of specific corrective actions below.

Your significant violations were as follows:

1. You must conduct, or have conducted for you, hazard analysis for each kind of fish or 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 did not have a HACCP plan for refrigerated, ready-to-eat canned crab meat to control the food safety hazard of Clostridium botulinum toxin formation.

Once you have conducted a hazard analysis for your seafood products, your HACCP plan must, at a minimum, list the hazards that are reasonably likely to occur, and include appropriate critical control points, critical limits, monitoring procedures, recordkeeping activities, etc., to ensure that the food safety hazards are controlled to comply with 123.6(c).

Your June 1, 2018 electronic response letter included a copy of your revised HACCP plan for pasteurized canned crabmeat. However, your response is inadequate because your HACCP plan does not contain, at a minimum, adequate critical limits, monitoring procedures or corrective action procedures.

2. Because you chose to include corrective actions in your HACCP plan, your described corrective actions must be appropriate to comply with 21 CFR 123.7(b). However, your corrective actions listed in your battered/breaded haddock HACCP plan at the "(b)(4)" and "(b)(4)" CCPs are not appropriate as they do not ensure the cause of the deviation is corrected as required by 21 CFR 123.7(b)(2).

Specifically, your corrective action is inadequate as it does not state how your firm will regain control of the operation after a critical limit deviation has occurred at the "(b)(4)" and "(b)(4)" CCPs. FDA recommends your corrective actions include procedures for ensuring the cause of a deviation is corrected to prevent recurrence.

Your June 1, 2018 electronic response letter included a copy of your revised HACCP plan for your battered/breaded haddock. However, your response is inadequate because your revised HACCP plan does specifically include corrections to your corrective actions procedures.

3. You must review critical control point monitoring records within one week after the records are made, to ensure compliance with 21 CFR 123.8(a)(3). Specifically, your "(b)(4)" monitoring records at the CCP "(b)(4)" for your battered/breaded haddock were not reviewed for the last year.

We acknowledge your response dated June 1, 2018 which states “The monitoring records for the (b)(4) will be maintained correctly as required”. However, your response is inadequate because you have not provided any evidence demonstrating that all monitoring records are receiving a weekly verification review by a HACCP trained individual in accordance with 21 CFR 123.10(c).

(b)(4)

As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law.

(b)(4)

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, the seafood HACCP regulation (21 CFR Part 123), the Current Good Manufacturing Practice regulation (21 CFR Part 117) and other applicable laws. 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, without limitation, seizure and 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 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)). 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 noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to 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 copies of records, revised HACCP plans, 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 fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Please send your reply to the Food and Drug Administration, Attention: Scott M. Loughan, Compliance Officer, 462 Welcome Center Road, Swanton, VT 05488. If you have questions regarding any issues in this letter, please contactMr. Loughanat 781-587-7619 or scott.loughan@fda.hhs.gov.

Sincerely,

/S/

Ronald Pace

Program Division Director

Office of Human and Animal Food Operations East – Division 1