Gonzalez and Nietos, LLC - 561490 - 11/29/2018

November 29, 2018

AMENDED WARNING LETTER

19-HAFE4-WL-03/CMS No. 561490

VIA UNITED PARCEL SERVICE

NEXT DAY - SIGNATURE REQUIRED

Andrew Gonzalez, Owner and Manager
Gonzalez and Nietos, LLC (formerly Loty International Wholesalers Corp.)
3320 NW 73rd Street
Miami, Florida 33147-5822

Dear Mr. Gonzalez

We inspected your food storage and distribution facility located at 3320 NW 73rd Street, Miami, FL on 5/15/2018 and 5/17/2018. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). In accordance with 21 CFR 123.6(g), failure of a seafood processor (which includes a facility such as yours that stores 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).

In addition, this inspection also revealed a serious violation of subpart B of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation, Title 21, Code of Federal Regulations, Part 117 [CGMP & PC regulation] (21 CFR Part 117).

Based on FDA’s findings during the inspection, your seafood products, such as salted herring and pollack, and other food products stored at your facility are adulterated, in that they havebeen prepared, packed or held under insanitary conditions whereby may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation, the CGMP & PC regulation, and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

At the conclusion of the inspection, we issued a FDA-483, Inspectional Observations, listing the deviations found at your firm. To this date, we have not received your firm’s response to the FDA-483.

Your significant violations were as follows:

Seafood HACCP Violation

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 refrigerated salted herring products to control the food safety hazard of scombrotoxin (histamine) formation.

In addition, we observed that your refrigerated salted boneless pollack products appear to be received in reduced oxygen packaging; therefore, the food safety hazard of Clostridium botulinum (C. bot) growth and toxin formation may be reasonably likely to occur. We recommend you verify the packaging with your supplier and address the C. bot hazard in a HACCP plan, if needed.

CGMP Subpart B Violation

You did not exclude pests from your food plant and use pesticides under precautions and restrictions to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, during the inspection of your facility, FDA investigator observed the following:

· One live cockroach on the wall along the east side of your freezer, under racking storing various food products.

· Three dead cockroaches in between packages of “United Sugars, Extra Fine Granulated, Pure Sugar Cane” packaged in 5lb paper bags. These packages were on a pallet along the wall on the west storage area, near the north end of the facility.

· An apparent birds’ nest along the ceiling in a center aisle, in the east storage area, across from the freezer and cooler.

· Apparent bird excreta on several boxes of “Loty Chicken Flavor Bouillon,” which were stored on a pallet near the wall shared with the south end of the freezer.

· Five dead cockroaches in Cooler #1 along the wall on both sides of the door. This cooler is used to store rice and other products which require a cool environment.

· Apparent cockroach parts (e.g., wings and exoskeleton parts) too numerous to count throughout your facility, along the east and center aisles in between racking systems, and along the walls.

· A powder, identified by your firm as a mix of corn flour and ground-up rodent bait blocks, throughout your entire facility along the walls, and in between racking systems of stored packaged food products. The bait was identified to be “Bell Contrac All Weather Blox” used to kill rats, mice and meadow voles.

· Your three dock doors used for shipping and receiving along the north end of the facility are open during business hours and are not screened to exclude any type of rodent or pest from entering the facility.

During the close-out discussion with the investigator, you indicated that your firm will look at purchasing screens for the dock doors to prevent rodent and pest entry into the facility, place bait stations around the exterior of the building, contact a pest control company to evaluate cockroach activity, and remove the birds’ nest. We acknowledge the voluntary corrective actions your firm has already taken before the conclusion of our inspection, such as removal of the flour/bait mixture in many areas. However, we have not received your firm’s written response, describing proposed corrective actions, the status of promise corrective actions, or how corrective actions you have taken will be sustained to prevent recurrence, to address the observations noted on the FDA-483, Inspectional Observations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, pest control records, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. If you do not believe that your products are in violation of the Act, include in your reasoning and any supporting documentation for our consideration.

This letter may not list all the violations at your facility. You are responsible for ensuring that your firm operates in compliance with the Act, the seafood HACCP regulation (21 CFR 123), and the CGMP & PC regulation (21 CFR 117). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations. Note that, although not covered by this inspection, you are subject to the preventive control requirements (primarily located in subparts C and G) of the CGMP and PC regulation, except for food subject to an exemption, such as seafood (21 CFR 117.5(b)). For more information about how the CGMP & PC regulation (21 CFR 117) affects processors and importers subject to the seafood HACCP regulation, see FDA’s guidance document, Seafood HACCP and the FDA Food Safety Modernization Act at https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM569798.pdf.

Please send your reply to the Food and Drug Administration, Office of Human and Animal Products, San Juan District Office, 466 Fernández Juncos Avenue, San Juan, PR 00901-3223, to the attention of Ramon Hernandez, District Director.

If you have any questions about this letter, contact Pearl Gonzalez, Compliance Officer, at (407) 475-4730 or via e-mail at pearl.gonzalez@fda.hhs.gov.

Sincerely yours,

/S/

Edwin Ramas

District Director, San Juan District

and Program Division Director,

OHAFO Division IV East

U.S. Food and Drug Administration

Gonzalez and Nietos, LLC MARCS-CMS 561490 — November 29, 2018