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WARNING LETTER

Flayco Products, Inc. MARCS-CMS 534460 —


Delivery Method:
VIA UNITED PARCEL SERVICE
Product:
Food & Beverages

Recipient:
Recipient Name
Mr. Jorge Astorquiza Sr.
Recipient Title
President
Flayco Products, Inc.

4823 N. Hale Ave
Tampa, FL 33614-6517
United States

Issuing Office:
Office of Human and Animal Food Operations East Division IV

United States


August 18, 2017

WARNING LETTER

17-OHAFOEDIV4-WL-08 / CMS No. 534460


Dear Mr. Astorquiza:

The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located in Tampa, FL, on April 10-11, 2017. During that inspection, we observed serious violations of Title 21, Code of Federal Regulations, Part 110, current Good Manufacturing Practices (cGMP), and Title 21, Code of Federal Regulations, Part 120, Juice Hazard Analysis and Critical Control Point (HACCP) regulation.

At the conclusion of the inspection, the FDA investigator issued to and discussed with you an FDA-483, Inspectional Observations, listing deviations found at your firm.

Significant violations are as follows:

1. Failure to take necessary precautions to protect against contamination of food, food contact surfaces, and food packaging systems with foreign substances as per 21 CFR 110(b)(9). Specifically,

a) Your packaging materials for your products include plastic gallon jugs, which were observed stored open and loosely covered with a piece of cardboard in a room that had apparent rodent excreta pellets too numerous to count.

b) Breezeway in between processing and storage buildings is not protected from the elements, has torn screen and is open partially to the outside.

c) Open containers, bags, boxes, of dry ingredients are stored partially uncovered in a warehouse that is joined by the unprotected breezeway that leads to the outside of the firm and the processing area.

d) Employees were observed leaving work stations during packaging of finished food products and not changing gloves when returning to work stations.

e) Employee observed picking up empty plastic food packaging bottles by placing un-gloved fingers into the bottle.

We acknowledge receipt of your firm’s written response on April 28, 2017. We have reviewed your firm’s written response and concluded that it does not adequately address the inspectional observations because it did not address the following concerns:

• Cleaning of the upstairs area where open packaging materials are stored adjacent to apparent rodent excreta pellets, too numerous to count, at one end of the packaging storage room
• Torn breezeway screen which provides possible rodent and/or insect entry from the outside into the product warehouse and processing.
• Retraining of employees to ensure that all ingredients that have been opened are closed securely to protect against airborne or outside contaminants.
• No training records of employees were supplied to show they were trained in the proper use of gloves during processing food items

2. During the inspection, your firm's grounds were littered with debris and tall vegetation which may constitute an attractant, breeding place, or harborage area for pests within the immediate vicinity of your facility as per 21 CFR 110.20(a)(1). Numerous routes for vermin and insects were observed from the inside of your firm via holes in and around doors, holes in screens, missing screens, and deteriorating concrete.

Your proposed corrective action including repairs made, removal of unused equipment, empty barrels, debris, and weeds from outside of the firm will be verified during the next scheduled inspection.

3. You do not have a written HACCP plan that outlines controls for one or more food safety hazards that are reasonably likely to occur in accordance with 21 CFR 120.8(a) for lime juice and lemon juice processed and packaged in your facility.

We acknowledge receipt of your firm’s written response on April 28, 2017. We have reviewed your firm’s written response and concluded that it does not adequately address the inspectional observation. For example, HACCP plan, hazard analysis or HACCP monitoring records were not provided.

4. You did not develop, or have developed for you, a written hazard analysis to determine whether there are food hazards that are reasonably likely to occur for juice you produce. Specifically, you do not have a Hazard Analysis for your lime juice and lemon juice in accordance with 21 CFR 120.7(a).

During the inspection, you informed the investigator an employee of your firm trained in Juice HACCP is responsible for all HACCP documentation. However, you failed to provide the information within 24 hours of the request. This is a repeat violation from previous inspections conducted in 2010 and 2011.

We acknowledge receipt of your response received on April 28, 2017. Your proposed corrective action of conducting private laboratory testing is inadequate in that private laboratory testing does not preclude your firm from following HACCP regulations applicable to the lemon juice and lime juice processed and packaged in your facility.

5. You do not maintain sanitation standard operating procedure records that document the monitoring of conditions and practices during processing and corrections to conditions and practices that were not met. Specifically, your firm lacks sanitation SOPs and monitoring documents in accordance with 21 CFR 120.6(c).

Your written response stating SSOPs were implemented is inadequate in that a copy of your SSOP’s and monitoring documents were not provided with your response. This information was conveyed to you by the investigator during the inspection. This is a repeat violation from previous inspections conducted in 2010 and 2011.

6. Your lemon juice and lime juice processed and packaged in your facility are not exempt from the 5-log performance standard since thermal concentration and final product packaging do not occur in a single facility. Your corrective action is inadequate in that your response did not address 5-log reduction in pertinent microorganisms in accordance with 21 CFR Part 120.24.

In accordance with cGMP regulation under 21 CFR Part 110 and Juice HACCP regulations under 21 CFR Part 120, lemon juice and lime juice processed and packaged at your facility is rendered to be 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 may have been rendered injurious to health. You may find the Act, the juice HACCP regulation, and the Juice HACCP Hazards and Controls Guidance through links in the FDA’s home page at http://www.fda.gov.

This letter may not list all the violations at your facility. You are responsible for ensuring that all of your products are in compliance with the applicable statutes and regulations administered by FDA. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action by FDA without further notice. Such action includes seizure of your products and/or injunction.

Further, 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 mean all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the inspection and assessing and collecting the 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.

You should respond in writing within fifteen (15) working days from receipt of this letter. Your response should outline the actions you plan to take in response to this letter, including an explanation of each step being taken to correct the current violations and prevent their recurrence. Include any documentation necessary to show that correction has been achieved. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the corrections.

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

Sincerely yours,

/S/

Maridalia Torres-Irizarry
District Director
OHAFO East Division lV