Inspections, Compliance, Enforcement, and Criminal Investigations

H & H Products Company 11/15/18

 

  

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Office of Regulatory Affairs
Office of Human and Animal Food Operations
Division IV East
Compliance Branch
466 Avenida Fernández Juncos
San Juan, Puerto Rico 00901-3223
Tel: (787) 729-8500 

November 15, 2018

WARNING LETTER
19-HAFE4-WL-02/CMS No. 565614

VIA UNITED PARCEL SERVICE
NEXT DAY AIR - SIGNATURE REQUIRED

Mr. Morris L. Hartley, Jr., President
H & H Products Company
6600 Magnolia Homes Rd.
Orlando, Florida 32810-4267

Dear Mr. Hartley:

The Food and Drug Administration (FDA) conducted an inspection of your food processing facility, located at 6600 Magnolia Homes Rd., Orlando, FL, from July 17-20, 2018. The inspection determined that your firm manufactures food products including juice and acidified foods. The inspection disclosed that you have serious repeat violations from the following regulations; Juice Hazard Analysis and Critical Control Point (HACCP), Title 21, Code of Federal Regulations, Part 120 (21 CFR 120), and Acidified Foods, Title 21, Code of Federal Regulations, Part 114 (21 CFR 114). Warning letter cites adulteration under section 402(a)(4) [21 U.S.C. § 342(a)(4)] of the Federal Food, drug, and Cosmetic Act (“the Act”).

Accordingly, we have determined that your juice concentrate products and acidified 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 have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. You may find the Act, the regulations for Juice HACCP, and Acidified Foods, and the Juice HACCP Hazards and Controls Guidance through links in FDA’s home page at www.fda.gov.

Please be aware that your firm was issued an Untitled Letter dated October 1, 2007; and a Warning Letter (WL) re: FLA-09-15 dated May 5, 2009 (enclosed). In addition, a Regulatory Meeting was held with your firm on March 22, 2011.

During our recent inspection of your facility, our investigator’s observations were noted on a Form FDA 483, Inspectional Observations, issued to you on July 20, 2018 at the closing of the inspection. We acknowledge receipt of your firm’s written response dated August 2, 2018, to the observations noted in the Form FDA 483. We address each response below in relation to each of the noted violations.

Juice HACCP Violations

As a juice processor, you are required to comply with the Act and pertinent regulations relating to the processing of juice products set forth in 21 CFR Part 120, Hazard Analysis and Critical Control Point (HACCP) and current good manufacturing practices (CGMP).

1. You must include in your HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, in the pertinent microorganism, as required by 21 CFR 120.24(a). Specifically, your HACCP plan for “Products With Concentrated Juices", which covers all of your single strength 100% juices, including: ascend brand 100% Lemon Juice, 100% Lime Juice, and 100% Key Lime Juice, as well as, Florida Key West brand 100% Lemon Juice and 100% Key Lime Juice, fails to list measures that would bring about a 5-log pathogen reduction in the pertinent microorganism. (A repeat observation from Untitled Letter dated October 1, 2007, Warning letter re:FLA-09-15 dated May 5, 2009, and inspections conducted in 2011 and 2018, respectively.)

We have reviewed your written response to Form FDA 483 dated August 2, 2018. Your response is inadequate. You did not provide evidence to document how you will avoid introducing single strength juice into commerce that has not undergone a 5-log pathogen reduction process; thus, we are unable to determine the adequacy of your corrective actions.

2. You do not conduct the 5-log reduction process and perform final packaging of your juice, within a single production facility, operating under current good manufacturing practices as required by 21 CFR 120.24(c). Specifically, you do not conduct a 5-log pathogen reduction process for any of your single strength juices, including: ascend brand 100% Lemon Juice, 100% Lime Juice, and 100% Key Lime Juice including Florida Key West brand 100% Lemon Juice and 100% Key Lime Juice.

During the inspection of July 17, 2018, our investigator observed these juices are blended and filled into their final packaging at your firm without receiving a 5-log pathogen reduction process, including the ascend brand 100% Lemon Juice, Lot #18-198, Best By July 17, 2019, which was blended and packaged.

We have reviewed your written response to Form FDA 483 dated August 2, 2018. Your response is inadequate. You did not did not explain how you will avoid introducing single strength juice into commerce that is not covered under a HACCP Plan that includes control measures that will consistently produce a 5-log pathogen reduction prior to implementing your new HACCP Plan; thus, we are unable to determine the adequacy of your corrective actions.

Acidified Foods Violation

As an acidified food processor, you are required to comply with the Act and the federal regulations related to the processing of acidified foods and current good manufacturing practices. These regulations are described in 21 CFR 114, Acidified Foods.

1. You must mark each container with an identifying code specifying the establishment where the product was packed and the product contained therein, as required by 21 CFR 114.80(b). Specifically, on July 19, 2018, our investigator observed the 1 oz. portion cup containers for your Hartley’s brand Sugar Free Pancake & Waffle Syrup, which is an acidified food, are not marked/identified with any code. Additionally, the identifying code on 12 oz. containers for your Hartley’s brand Sugar Free Pancake & Waffle Syrup does not specify the establishment where the product was packed, the product contained therein, and the packing period. The bottles are only coded with the production date and best by date. For example:

• The identifying code ink-jetted on to 12 oz. containers of Hartley’s brand Sugar Free Pancake & Waffle Syrup that was produced during the inspection on 7/19/2018 reads: “18-200 BB 01/16/19”

• "18" = Production year (2018); “200” = Production Julian date (July 19th); and “BB 01/16/19” = 6-month shelf life.

We have reviewed your written response to Form FDA 483 dated August 2, 2018. Your response is inadequate. You did not provide details, nor documentation evidence on how you plan on accomplishing the coding process for your 1 oz. cups and you did not explain how you will avoid introducing acidified foods into commerce which either lack an identifying code (1 oz. cups) or do not contain all the required code elements (12 oz. bottles) prior to implementing the new processes.

Further, we have reviewed your written response to Form FDA 483 dated August 2, 2018, for Observation# 3, you did not mention nor provide any evidence of any internal investigation and/or consultation with your Process Authority regarding the pH deviation of Hartley's brand Sugar Free Pancake & Waffle Syrup, Batch #97751, Lot #18-031, which you shipped in commerce after recording a final pH of 4.58, deviating from their maximum equilibrium pH of 4.50.

Additionally, we have reviewed your written response to Form FDA 483 dated August 2, 2018, for Observation# 4, 6, and 7 and they were adequately addressed and corrected. We will verify the adequacy of your proposed corrective action during our next inspection.

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 juice HACCP regulation (21 CFR 120), the Acidified Foods regulation (21 CFR 114) and applicable regulations. You also have a responsibility to use procedures to prevent further violations of the Federal Food, Drug, and Cosmetic Act and all applicable regulations.

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)]. 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. You should 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 believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

If you have any questions regarding this letter, please contact Ms. Beira Montalvo, Compliance Officer, at (561) 416-1065, Ext. 1108, or via e-mail at Beira.Montalvo@fda.hhs.gov.

Your written response to this letter should be sent to the attention of: Ramon A. Hernandez, Program Division Director, Food and Drug Administration, Office of Human and Animal Food Operations, Division IV East, 466 Fernández Juncos Avenue, San Juan, Puerto Rico 00901-3223.

 

Sincerely yours,
/S/
Ramon A. Hernandez
Director, San Juan District Office
and Program Division Director,
Office of Human and Animal Food Operations, Division IV East
 

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