Maui Preserved, LLC - 561637 - 08/10/2018

WARNING LETTER

VIA CERTIFIED MAIL

WL# 561637

August 10, 2018

Mr. Anthony M. Labua-Keiser

Maui Preserved, LLC

810 Kokomo Rd Ste 150

Haiku, HI 96708-5081

Dear Mr. Labua-Keiser:

On April 30-May 3, 2018, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 810 Kokomo Rd Ste 150 Haiku, Hawaii, where you manufacture shelf-stable, ready-to-eat hot sauces, which are acidified foods. The inspection revealed serious violations of the regulations for acidified foods [Title 21, Code of Federal Regulations, Part 108, Emergency Permit control (21 CFR 108) and Part 114, Acidified Foods (21 CFR 114)]. Accordingly, we have determined your acidified food products are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 United States Code (USC) 342(a)(4)], because 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 can find the Act and applicable regulations through links in FDA’s Internet homepage at www.fda.gov.

As a manufacturer of acidified food products, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations relating to the processing of acidified food products. The Emergency Permit Control regulations were issued, in part, pursuant to Section 404 of the Act, Emergency Permit Control, 21 USC 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in hermetically sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR 114. Regulations specific to the processing of acidified food products are described in 21 CFR 108 and 21 CFR 114. As outlined in these regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR 108.25 and 21 CFR 114 could be subjected to an immediate application of the emergency permit control provisions of Section 404 of the Act (21 USC 344). Violation of the mandatory requirements set forth in 21 CFR 108.25 and 21 CFR 114 renders your acidified food products adulterated within the meaning of Section 402(a)(4) of the Act, 21 USC 342(a)(4).

1. Your firm failed to provide the FDA, before packing any new product, information on the scheduled process from a qualified processing authority filed with FDA for your Thai Chile Hot Sauce and Hot Hot Sauce, as required by 21 CFR 108.25(c)(2), Specifically, there is no scheduled process on file for this product.

As a commercial processor engaged in the thermal processing of acidified foods, you must provide the FDA information as to the scheduled processes, including conditions for heat processing and control of pH, salt, sugar, and preservative level and source and date of the establishment of the process, for each acidified food in each container size, as required by 21 CFR 108.25(c)(2).

Scheduled process information for acidified foods must be submitted on Form FDA 2541e a (Food Process Filing for Acidified Method). More information on registration and filing can be found in the publication " Guidance for Industry: Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format'' available at: https://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation/ucm309376.

2. Your firm failed to mark your acidified product bottles with an identifying code permanently visible to the naked eye which specify the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed as required by 21 CFR 114.80(b). Specifically, the 8-digit code on your acidified food containers do not include the establishment where the product was packed, the name of the product and the date the product was processed.

Each container or product shall be marked with an identifying code permanently visible to the naked eye. If the container does not permit the code to be embossed or inked, the label may be legibly perforated or otherwise marked, as long as the label is securely affixed to the product container. The required identification shall specify in code the establishment where the product was packed, the product contained therein, and the year, day, and period during which it was packed. The packing period code shall be changed often enough to enable ready identification of lots during their sale and distribution. Codes may be changed periodically on one of the following bases: intervals of 4 to 5 hours; personnel shift changes; or batches, as long as the containers constituting the batch do not represent those processed during more than one personnel shift, as required by 21 CFR 114.80(b).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, 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 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 reinspection 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 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. Refer to the Unique Identification Number 509695 when replying.

Your response should be sent to:

Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Compliance Branch, HAF Division West 5, HFR-PA150
19701 Fairchild
Irvine, CA 92612

If you have any questions about the content of this letter, please contact Sara J. Dent Acosta, Compliance Officer, at 619-941-3767.

Sincerely,

/S/

Darla Bracy, Director

Office of Human and Animal Foods

Division 5 West

US Food and Drug Administration