WARNING LETTER
Rongcheng Jiayuan Food Co., Ltd
MARCS-CMS 682456 —
May 31, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. LiBo Yu
Recipient Title
General Manager
Rongcheng Jiayuan Food Co., Ltd
No. 186 Longyu Road
Rongcheng Shi
Weihai Shi
Shandong Sheng
,
264311
China
libo.yu@jy-group.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
May 31, 2024
Reference # 682456
Dear Mr. LiBo Yu:
The U.S. Food and Drug Administration (FDA) inspected your seafood and low acid canned food (LACF) facility, Rongcheng Jiayuan Foods (3rd Workshop) Co., Ltd., located at No. 299 Fenghuang Road, Rongcheng, Weihei, Shandong Province, China, on November 9 and 10, 2023. During that inspection we found that your firm had serious deviations from the Seafood HACCP regulation (21 CFR Part 123) and the Emergency Permit Control regulation (Title 21, Code of Federal Regulations, Part 108 (21 CFR Part 108), the Low Acid Canned Foods regulation (21 CFR Part 113). At the conclusion of the inspection, the FDA investigator issued an FDA-483, Inspectional Observations that lists the observations made at your firm. To date, FDA has not received a response from you regarding the inspectional observations documented during the inspection of your facility.
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 canned tuna products, are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazards Guide) through links in FDA's home page at www.fda.gov.
Additionally, as a manufacture of LACF products intended for export to the United States, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the regulations promulgated under the Act. The Emergency Permit Control regulations were issued, in part, pursuant to section 404 of the Act, Emergency Permit Control, 21 U.S.C. § 344. A temporary emergency permit may be required for thermally processed low-acid foods packaged in
(b)(4)
sealed containers and acidified foods whenever a processor has failed to fulfill the requirements of 21 CFR Part 108.25, including registration and filing of process information, and the mandatory requirements in 21 CFR Part 113. Regulations specific to the processing of LACF products are described in 21 CFR Part 108, and 21 CFR Part 113.
As outlined in the regulations, a commercial processor that does not adhere to all of the mandatory requirements of 21 CFR Part 108.25, and 21 CFR Part 113 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. 344). As stated in 21 CFR 108.25(j), for imported products, in lieu of issuing an order of determination that a permit is required before products from a commercial processor can be introduced into interstate commerce, FDA may take steps to refuse admission of the commercial processor's products under section 801 of the Act (21 U.S.C. 381) when offered for entry into the United States. Violation of the mandatory requirements set forth in 21 CFR Part 108.25, and 21 CFR Part 113 renders your LACF food products adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). You can find the Act and Acidified Food regulations through links in FDA’s home page at www.fda.gov.
Your significant violations are as follows:
Seafood HACCP Regulation, 21 CFR Part 123
1. Your HACCP Plan does not list the food safety hazards that are reasonably likely to occur as required by 21 CFR 123.6(c)(1). Specifically, your firm’s process for this product includes the
(b)(4)
. Your firm has not identified the hazard of Staphylococcus aureus growth and toxin formation. S. aureus is a reasonably likely hazard for both the frozen rounds and frozen fillets thawed and processed by your firm at ambient processing temperatures ranging from
(b)(4)
°C (
(b)(4)
° F). Either exposure times and/or ambient temperatures should be controlled. For example, when ambient temperatures exceed
(b)(4)
°C, but remain below
(b)(4)
°F, temperatures should be monitored. If ambient temperatures have the possibility of exceeding
(b)(4)
°F, then cumulative exposure times should be limited to less than
(b)(4)
.
2. You must have a HACCP plan that at 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 “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 HACCP plan for “Canned Tuna HACCP Plan, file JY/C-Z-40 version B/1” does not list a critical limit that ensures control of one or more hazards. Your firm receives frozen whole fish from harvest vessels as a primary (first) processor. FDA recommends that primary processors implement critical limits to ensure handling conditions aboard harvest vessels are safe. The HACCP plan lists critical limits at the Receiving (Round frozen, CCP 1-1) critical control point which are not adequate to control the hazard of histamine formation. Specifically,
a. Your current critical limit of incoming fish is for histamine not to exceed
(b)(4)
ppm. Your firm’s practice is to composite samples from three fish and test the composite mixture for histamine. When multiple fish samples are composited, critical limits should be adjusted to accommodate the multiple fish. For example, when samples from 3 fish are composited the critical limit for histamine should be lowered to 17ppm to accommodate samples collected from three fish.
b. Your critical control point does not list a critical limit for sensory evaluation of fish for smells of decomposition. FDA recommends that the presence of decomposition in vessel lot should be less than 2.5%. For example, no more than 2 fish in a sample of 118 fish may show signs of decomposition.
3. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b). Specifically:
a. Your firm did not implement your HACCP Plan “
(b)(4)
” for “
(b)(4)
. Cumulative time of raw material picking, metal detection, secondary picking of raw materials, weighing canning and other processes.” No record documenting the monitoring of cumulative processing time from
(b)(4)
to canning was provided to FDA.
b. Your HACCP plan requires at
(b)(4)
, the monitoring procedures of “
(b)(4)
” and “
(b)(4)
” for the critical limit of “The
(b)(4)
time should not over
(b)(4)
. The raw material temperature is controlled below
(b)(4)
°C”. The monitoring record “
(b)(4)
” documents the “
(b)(4)
” of
(b)(4)
time and
(b)(4)
temperatures at the “
(b)(4)
”. The
(b)(4)
times for the record
(b)(4)
showed multiple lots
(b)(4)
for
(b)(4)
and do not include hourly checks.
4. Since you chose to include corrective actions in your HACCP Plan, your described corrective actions must be appropriate, to comply with 21 CFR 123.7(b). However, your corrective action plan listed at the following critical control points are not appropriate. Specifically:
a.
(b)(4)
, critical limit for the workshop environment temperature of
(b)(4)
°C require monitoring “
(b)(4)
”. The monitoring record “
(b)(4)
” does not include this information.
b.
(b)(4)
,
(b)(4)
Time, temperature for “
(b)(4)
” lists a corrective action of “
(b)(4)
.” The corrective action does not address when the critical limit for ambient temperatures in the
(b)(4)
room (
(b)(4)
°C) is exceeded nor does it address how the cause of the deviation will be addressed.
c.
(b)(4)
, the corrective action for the critical limit for time from
(b)(4)
to canning for “
(b)(4)
” does not address how the cause of the deviation will be corrected.
d.
(b)(4)
, “
(b)(4)
” lists the corrective action of “
(b)(4)
.” This corrective action does not address how the cause (e.g., source of the labels) of the deviation will be addressed. FDA recommend that in addition to addressing the labeled product, all remaining labels be reviewed for correctness and following up with the label supplier to prevent a reoccurrence of the problem.
LACF Regulation, 21 CFR Part 113
5. The operator did not record the water level in the retort at intervals sufficient to ensure its adequacy. Specifically, your firm’s records for all retorted products include once/load check of the water level. This check must be made throughout the process to ensure that water covers all pouches within the retort as required by 21 CFR part 113.40(b)(10).
6. The suction outlets were not protected with non-clogging screens or other suitable means of preventing debris from entering the circulating system. During the retort survey conducted 11/10/2023, the drain lines for the water circulation system were noted to have only a single bar across the opening, not suitable to prevent debris from entering the system as required by 21 CFR part 113(b)(11).
You should respond in writing within (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. More specifically, your response should include documentation and information that would assist us in evaluating your corrections such as copies of your updated process filings and completed processing records demonstrating your firm’s ability to adhere to your scheduled process and monitoring of critical factors. If you cannot complete all corrections within 15 days, 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 your reasoning and any supporting information for our consideration.
If you do not respond or if we find your response inadequate, we may take further action. For instance, we may take further action to refuse admission of your imported canned tuna products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on detention without physical examination (DWPE). FDA’s DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA’s Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with the seafood HACCP regulation is Import Alert #16-120 and Import Alert #99-38, Detention without Physical Examination of Low-Acid Canned Foods and Acidified Foods due to Inadequate Process Control. These alerts can be found on FDA’s web site at https://www.accessdata.fda.gov/cms_ia/importalert_1132.html and http://www.accessdata.fda.gov/cms_ia/ialist.html.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR Parts 108, LACF 21 CFR Part 113), the CGMP & PC rule (21 CFR Part 117), and Seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Rosemary Sexton, Compliance Officer, Food Adulteration Assessment Branch, Office of Compliance, Division of Enforcement, 5001 Campus Drive, College Park, MD 20740 U.S.A., or send via email at rosemary.sexton@fda.hhs.gov. Please reference CMS 682456 on any submissions and within the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham J.D.
Director
Office of Compliance
Center for Food
Safety and Applied
Nutrition
Content current as of:
11/12/2024
Regulated Product(s)
Food & Beverages