WARNING LETTER
Amor Nino Foods, Inc.
MARCS-CMS 652778 —
June 26, 2023
Delivery Method:
VIA UNITED PARCEL SERVICE SIGNATURE REQUIRED
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Amor Nino
Recipient Title
President
Amor Nino Foods, Inc.
1928 Homerule Street
Honolulu
,
HI
96819
United States
Issuing Office:
Division of Human and Animal Food Operations West V
United States
WARNING LETTER
June 26, 2023
WL 652778
Dear Mr. Nino:
The United States Food and Drug Administration (FDA) inspected your seafood processing facility located at 1928 Homerule Street, Honolulu, HI from January 11 to January 24, 2023. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123, and the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC rule), Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). 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 ready to eat (RTE) Hawaiian Style Aku (Skipjack Tuna) Sticks are adulterated, in that they have 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 home page at www.fda.gov.
At the conclusion of the inspection, the FDA investigator issued your facility a Form FDA 483, Inspectional Observations. You provided a written response to the inspection on February 13, 2023 which included corrective actions taken by your firm. We have reviewed the documentation and continue to have serious concerns with your HACCP program.
Your significant deviations were as follows:
1. You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for ready to eat, Hawaiian Style Skipjack Tuna Sticks (Hawaiian Style Aku Sticks) lists critical limits that are inadequate to control the hazards of Scombrotoxin formation and pathogen growth and toxin formation, specifically S. aureus toxin formation:
a. At the “
(b)(4)
” critical control point, the listed critical limits “minimum drying time:
(b)(4)
” and “Minimum product drying temperature
(b)(4)
”.
b. At the “
(b)(4)
” critical control point, the listed critical limits “Incorrect measurements of ingredients may increase the risk of either over dosing of
(b)(4)
and/or increase the risk of pathogenic growth due to inadequate
(b)(4)
”.
In addition, you have not conducted a validated study to demonstrate the critical limits under your current operating conditions will prevent the formation of histamine and the growth of pathogens during the drying process. Further, you stopped implementing the verification procedure of analytical testing
(b)(4)
at these critical control points in July 2019.
Your critical limits must be established by a scientific study to assure that your partially dried Aku strips reach a safe water activity within
(b)(4)
is sufficient to prevent the hazards from
(b)(4)
. Further, 21 CFR 172.175 allows the use of the food additive sodium nitrate if it is used or intended for use as a color fixative in smoked cured tuna fish products so that the level of sodium nitrite does not exceed 10 parts per million (0.001 percent) in the finished product.
(b)(4)
is made in part of sodium nitrate; therefore, your critical limit of “
(b)(4)
” may not exceed the established tolerance level for this food additive.
Your written response explained you made personnel changes to your HACCP team and employees have been retrained on procedures, policies and recordkeeping. We acknowledge that you have enrolled your new assistant HACCP coordinator in a Seafood HACCP course; however, you did not provide evidence to demonstrate other employee training has been performed. In addition, you stated you reinstated your verification procedure of finished product testing and provided a copy of analytical results dated 01/25/2023. However, the results do not demonstrate at what point in your process the product attains a
(b)(4)
which will mitigate the Scombrotoxin and pathogen hazards. Further, you indicated that you plan to conduct a validation study to support your current processes;
(b)(4)
.” This does not provide assurance that you have conducted a scientific study to validate your current processes and establish appropriate critical limits.
2. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not implement the monitoring procedures at the following critical control points listed in your HACCP plan for Hawaiian Style Skipjack Tuna Sticks (Hawaiian Style Aku Sticks) to control Scombrotoxin formation and pathogen growth and toxin formation, specifically S. aureus:
a. At “
(b)(4)
” critical control point, the procedure is “Continuouse temperature monitoring device with alerts & alarms via sound, text messaging, & email.” You do not have a continuous temperature monitoring device at your
(b)(4)
chill storage. Our investigator observed you are monitoring temperature
(b)(4)
per production day using a probe thermometer. This procedure is not what your plan requires and is not adequate to ensure that a proper temperature is maintained in the cooler.
In addition, we noted a discrepancy with the monitoring procedure. While continuous temperature monitoring during storage is accomplished by the device itself, we recommend a visual check of the recorded data at least once per day.
b. At “
(b)(4)
” critical control point lists a procedure of “Start time and end time of
(b)(4)
temperature” for the critical limit of “Minimum
(b)(4)
temperature:
(b)(4)
.” Our investigator observed you are not implementing this procedure. Further, you do not maintain records of monitoring.
These are repeat observations from your FDA inspection that ended on September 12, 2019.
Your written response indicated that you ordered a data logger and temperature probe. Further, you promised to implement use upon receipt and employee training. You also provided a
(b)(4)
Log template. We find your response inadequate in that you did not provide evidence to demonstrate that you are implementing these monitoring procedures.
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility or 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 ensure that your firm complies with all requirements of federal law, including FDA regulations. You should take prompt action to address the violations noted in this letter. Failure to promptly address these violations may result in legal action without further notice, including, without limitation, seizure, injunction, or administrative action for suspension of food facility registration if criteria and conditions warrant.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number
652778
when replying.
If you prefer to send your response electronically, please email it to ORAHAFWEST5FirmResponses@fda.hhs.gov. Please include the name of your firm and the Unique Identification number in the title of the e-mail message.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at kimberly.lichter@fda.hhs.gov or (949) 608-2967.
Sincerely,
/S/
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5
Content current as of:
08/29/2023
Regulated Product(s)
Food & Beverages