As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent.
Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.
Yakseon Food Agricultural Co. LTD
Tae-Eun Kim, owner
Feb. 11, 2020
The U.S. Food and Drug Administration (FDA) inspected the low-acid canned food (LACF) facility located at 1306 Gyeongdong-ro, Andong-si, Gyeongsangbuk-do 36728, Republic of Korea on Oct. 17-18, 2019. Inspectors found serious deviations from the federal law regarding Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. At the conclusion of the inspection, the FDA investigator issued an FDA-483 lnspectional Observations Form that lists the serious deviations found at your firm. FDA acknowledged receipt of a response received Nov. 7, 2019. Evaluation revealed the response was not adequate, as further described in this letter.
Significant violations cited by the FDA in its letter to the company owner included:
Your firm did not provide evidence that the scheduled processes for the low-acid food products that you manufacture were established by a qualified person who has expert knowledge acquired through appropriate training and experience in thermal processing requirements for low-acid foods in hermetically sealed containers. Your firm has not established the critical parameters such as minimum time and temperature for processing in that you have not conducted temperature distribution, heat transfer rate, and heat distribution studies in your (redacted by FDA) retort used for processing low-acid canned foods. Your response states you will conduct the referenced studies. This response does not provide a timeframe for completion or identify the processing authority you will work with to establish the critical factors.
2. Your firm did not ensure your (redacted) processing system, redacted) retort, was operated in a manner to ensure commercial sterility was achieved, as critical parameters were not measured and recorded at intervals of sufficient frequency to ensure they were within the limits of federal law. Specifically, your (redacted) retort does not have the following instrumentation: temperature-indicating device (TID), temperature recording chart, or mechanism to control (redacted) mixture.
Temperature information is critical to ensure the process has achieved a commercially sterile product. Your response states you will work with the retort company to install necessary devices to control the process, but you have not provided a timeframe for completion nor have you provided copies of invoices or work orders demonstrating this work has been scheduled or completed.
3. Your firm did not measure the initial temperature of the low-acid foods in their containers prior to processing to ensure the temperature of the product is no lower than the minimum initial temperature specified in the scheduled process as required by federal law. You are not capturing and documenting important processing information to ensure all the required information, including critical factors, are documented as specified in the scheduled process(es) and recorded. You response states you will determine the initial temperature of the LACF products prior to processing at sufficient frequency so that it is not below the minimum initial temperature in the scheduled process, but you have not identified how and at what frequency the initial temperature will be monitored, nor have you provided documentation you are recording the initial temperature.
4. Your firm does not conduct any container integrity testing, visual or destructive on any products as required by federal law. Your response states you will conduct container integrity testing, but you have not provided any documentation describing the types of tests, frequency for which the tests will be performed, or how the tests will be documented.
5. You must have plant personnel involved in thermal processing systems or other critical factors of the operation under the operating supervision of a person who has attended a school approved by FDA to comply with pertinent federal law. Specifically, our inspection revealed no one at your firm has received training in critical factors in the production of LACF products.Your response states you will attend a Better Process Control School in February 2020, but you have not provided documentation demonstrating you have registered to attend or completed this training.
The FDA sent a process inquiry Nov. 4, 2019, for which it had not received a response as of the sending of the warning letter.
“Previously filed scheduled processes are no longer valid. Prior to shipping to the U.S., you should to ensure all scheduled processes are current and filed appropriately,” according to the letter. “If you do not respond to this letter or if we find your response inadequate, we may take further action. For instance, we may take action to refuse admission of your imported LACF and acidified paste and sauce products under section 801(a) of the Act (21 U.S.C. 381(a)) including placing them on detention without physical examination (DWPE).”
Lemond Trading Corp.
Nam Ho Kang, general manager
Feb. 10, 2020
On Nov. 25 and 26, 2019, the Food and Drug Administration conducted a Foreign Supplier Verification Program (FSVP) inspection at Lemond Trading Corp., 4461 Malaai Street, Honolulu, HI 96818. The agency also conducted an inspection on July 24, 2018. These inspections were conducted to determine compliance with the requirements of federal law including the Foreign Supplier Verification Program (FSVP).
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards.
During the most recent inspection, we found that you are not in compliance with requirements for any food products you import including but not limited to, red pepper powder, frozen noodles, frozen fried rice, soup stock, assorted frozen dumpling, assorted buns, frozen fried seaweed, cookies, soy bean paste, fried soybean curd, fried seaweed wrapped vermicelli rolls, and seasonings from your foreign supplier, (redacted by FDA), located in the (redacted).
At the conclusion of both the initial FSVP inspection, and the follow-up inspection on Nov. 25-26, 2019, our investigator provided the company’s general manager with a Form FDA 483a FSVP Observations Form.
The FDA acknowledged receipt of the company’s response dated Nov. 27, 2019, but said it was inadequate.
“In your letter, you asked for guidance on where to find information on the requirements for FSVP,” according to the FDA warning.
“During the inspection our investigator provided you with documents entitled, ‘FSVP Final Rule on Foreign Supplier Verification Programs,’ and ‘Key Requirements on Foreign Supplier Verification Programs,’ which explained the requirements to you.”
Luoma Egg Ranch Inc.
Judy M. Luoma, president
Dec. 10, 2019
The United States Food and Drug Administration (FDA) inspected your shell egg farm located at 35705 State Highway 18, Finlayson, MN, from June 18 – 21, 2019. The inspection revealed serious violations of the Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation regulation in the federal code.
Failure to comply causes your shell eggs to be adulterated 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.
“We received your written response dated June 30, 2019, concerning our investigators’ observations noted on the Form FDA-483 (FDA-483), lnspectional Observations, which was issued on June 21, 2019, at the conclusion of our inspection,” the FDA warning letter states.
“Our review reveals that your response is inadequate, as further explained in this letter.”
The significant violations described by the FDA in its warning letter include, but are not limited to:
1. Your firm failed to conduct environmental testing when hens are 40-45 weeks of age, as required by federal law. The company was not able to provide documentation indicating that environmental testing was conducted in poultry houses when the laying hens were 40 to 45 weeks of age. “Your response states that the requirement was misinterpreted, and that your veterinarian would visit the farm and retrain employees on correct SE sampling procedures. Your response did not include any documentation that the retraining occurred or provide the content of the training. Any retraining effort should include a review of required time-points at which samples must be taken. Based on your response, we are unable to determine if this concern was addressed,” FDA officials wrote in the warning letter.
2. Your firm failed to hold your eggs intended to be used as table eggs at or below 45°F beginning 36 hours after the time of lay, as required by federal law.
3. Your firm failed to use appropriate monitoring methods to monitor for flies, as required by federal law. “. . . our investigators observed flies too numerous to count . . . indicating that your monitoring method is inadequate.,” according to the warning letter.
Furthermore, you do not record certain information on your rodent monitoring records. Further, your plan does not provide a threshold level of unacceptable rodent activity within a poultry house. Without a threshold, it is impossible to determine an unacceptable level of rodent activity, according to the warning letter.
4. Your firm did not remove debris outside a poultry house that may provide harborage for pests. Specifically, FDA investigators observed debris, including trash.
5. Your Salmonella Enteritidis prevention plan did not include measures to properly maintain biosecurity practices to protect against cross-contamination when equipment and people are moved between poultry houses.
6. Your firm failed to implement bioscurity practices to limit the number of visitors on the farm and in the poultry houses. FDA investigators observed multiple truck drivers and refrigeration repair personnel coming and going into the egg washing, egg packing, egg storage, and barn areas without following your biosecurity practices.
Kakushime Matsuda Suisan
Kazunori Matsuda, owner
Sept. 18, 2019
The United States Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Kakushime Matsuda Suisan, Hakodate, located at 247 Furukawa-Cho, Hakidate, Hokkai-do, Japan on July 8 and 9, 2019. During that inspection, we found that you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation of U.S. federal law. At the conclusion of the inspection, the FDA investigator issued an FDA-483 lnspectional Observations Form, listing the observations made at your firm.
“We acknowledge receipt of your response sent via email on July 17, 2019,” according to the FDA’s warning. “Your response included a revised hazard analysis and HACCP plan entitled ‘Control; of Raw Herring Process’ dated July 17, 2019, that covers your herring products, and product label for ‘Herring Split.’ However, our evaluation of your response revealed it was not adequate, as further described in this letter.”
In accordance with federal law, 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 the applicable federal law, renders the fish and fishery products adulterated. Accordingly, your frozen, (redacted by FDA) packaged salted and partially dried herring products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
Significant deviations included:
Lack of a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points. Your plan does not list critical control points for controlling the food safety hazards of scombrotoxin (histamine) formation, pathogen growth and Clostridium Botulinum in your frozen (redacted) packaged salted and partially dried scombroid-species fish products. Specifically, your revised HACCP plan does not list a critical control point (CCP) of:
a. Your firm thaws the frozen herring in ambient temperature water (redacted)°C (redacted)°F)) for approximately (redacted) hours. FDA recommends that thawing be conducted under refrigeration of 40°F (4.4°C) or below with continuous temperature monitoring with a visual check of the recorded data at least daily.
b. Your firm brines herring in an ambient production room for approximately (redacted) hours and herring roe in an ambient production room for approximately (redacted) hours. FDA recommends that brining be conducted under refrigeration of 40°F (4.4°C) or below with continuous temperature monitoring with a visual check of the recorded data at least daily.
c. Your firm partially dries herring stuffed with salted roe in drying chambers at approximately (redacted)°C ((redacted)°F) for at least (readcted) hours. FDA recommends that drying be conducted under refrigeration of 40°F (4.4°C) or below with continuous temperature monitoring with a visual check of the recorded data at least daily.
d. Your firm’s herring products are distributed frozen in (redacted) packaging. If mishandling, this type of packaging creates an environment which is conducive to C. botulinum growth and toxin formation. Therefore, FDA recommends that your HACCP plan include appropriate controls to ensure each product is appropriately labeled with handling instructions (e.g., “Important, keep frozen until used, thaw under refrigeration immediately before use”).
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