WARNING LETTER
Dalian Lingfa Food Co., Ltd.
MARCS-CMS 681016 —
June 03, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Ping Ling Huang, Owner
Recipient Title
Mr. Zhen Guo Zhao, Owner/General Manager
Dalian Lingfa Food Co., Ltd.
Dengshahe Town
Jinzhou Qu
Dalian Shi
Liaoning Sheng
,
116105
China
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
June 3, 2024
WARNING LETTER
Reference # 681016
Dear Mr. Huang:
The United States (U.S.) Food and Drug Administration (FDA) inspected your food manufacturing facility, located at Dengshahe Town, Jinzhou District, Dalian, Liaoning, 116105, China on January 17 - 19, 2024. Your facility manufactures refrigerated ready-to-eat (RTE) vegetables in vacuum packaging. During the inspection, FDA investigators found serious violations of 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). At the conclusion of the inspection, FDA issued a Form FDA 483 (FDA-483), Inspectional Observations, listing the deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the refrigerated RTE vacuum packaged seasoned bamboo shoot products manufactured in your facility 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 were prepared, packed, or held under conditions whereby they may have become rendered injurious to health. In addition, failure of the owner, operator, or agent in charge of a covered facility to comply with the preventive controls provisions of the CGMP & PC rule (located in Subparts A, C, D, E, F, and G of Part 117) is prohibited by Section 301(uu) of the Act [21 U.S.C. § 331(uu)]. You may find the Act and FDA’s regulations through links in FDA’s home page at http://www.fda.gov/.
We acknowledge receipt of your responses, received via email on February 2 and 26, 2024, which included a written statement, an updated HACCP plan, monitoring records, and shipping documents. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s concerns and to provide detailed information describing the findings at your facility. We address your responses below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. Your hazard analysis did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it requires a preventive control, as required by 21 CFR § 117.130(a)(1). Specifically, your hazard analysis for the seasoned bamboo shoots did not consider the hazard of pathogenic bacterial outgrowth and toxin formation due to reduced oxygen packaging, specifically
Clostridium botulinum (C. botulinum)
, during your processing steps of
(b)(4)
and finished product storage. Your RTE vegetable products (including bamboo shoots) are vacuum packaged, creating an anaerobic atmosphere favorable for outgrowth and toxin formation of
C. botulinum
. Therefore, bacterial outgrowth and toxin formation due to reduced oxygen packaging, specifically
C. botulinum
, is a known or reasonably foreseeable hazard at the
(b)(4)
steps. A knowledgeable person manufacturing/processing food in your circumstances would identify bacterial outgrowth and toxin formation of
C. botulinum
due to reduced oxygen packaging as a hazard requiring a preventive control. Preventive controls include, as appropriate to the facility and the food, process controls (see 21 CFR § 117.135(c)(1)). Process controls include procedures, practices, and processes to ensure the control of parameters during operations, and must include the parameters associated with the control of the hazard and the minimum and maximum values needed to significantly minimize or prevent the hazards (see 21 CFR § 117.135(c)(1)). Such controls for your seasoned bamboo shoots could include formulation (e.g., decreasing pH to below
(b)(4)
or water activity to below
(b)(4)
),
(b)(4)
processing (e.g., a cooking temperature and duration that is lethal to proteolytic
C. botulinum
), or refrigeration (e.g., temperature control below
(b)(4)
°C). Your seasoned bamboo shoot products do not undergo any of these measures. For example, your seasoned bamboo shoot products do not receive a treatment lethal to proteolytic
C. botulinum
before or after packaging, and your formulation does not control for the outgrowth and toxin formation of
C. botulinum
. Additionally, the following observations specifically demonstrate that you did not adequately control for bacterial outgrowth and toxin formation (i.e., proteolytic
C. botulinum
) due to reduced oxygen packaging:
On January 17, 2024, the investigator observed numerous bags of TETSUJIN brand Seasoned Bamboo Shoots (in 1kg vacuum packaged plastic pouches intended for the U.S. market) being staged in an unrefrigerated room. According to your staff, the product had been staged there for at least 24 hours. This staging room was not equipped with a thermometer. You were not monitoring the temperature of the product staging room, where you temporarily hold RTE vacuum packaged seasoned bamboo shoots after the
(b)(4)
steps, and prior to secondary carton packaging. Furthermore, review of your production records in November and December 2023 for RTE vacuum packaged seasoned bamboo shoots (for the U.S. market) revealed that you stored the product in the unrefrigerated staging room for a range of approximately 1-6 days without any form of temperature monitoring.
According to your temperature and humidity record for the refrigerated warehouse, after secondary carton packaging, your RTE vacuum packaged seasoned bamboo shoots are to be maintained at a temperature between
(b)(4)
°C -
(b)(4)
°C. You document the digital temperature reading twice per day (morning and afternoon). However, a review of your records revealed numerous occasions in May 2023, June 2023, July 2023, August 2023, and October 2023 where the temperature exceeded
(b)(4)
°C, the temperature that proteolytic
C. botulinum
may outgrow and form toxin.
In your response, you provided documents including a written statement, updated HACCP plan for RTE vacuum packaged vegetables, monitoring records for non-finished product refrigerated storage (i.e., staging room) and final product refrigerated storage, and shipping documents. You stated in the written statement that
(b)(4)
.” In addition, your updated HACCP plan includes a critical control point, (CCP 6), to prevent against the hazard of
C. botulinum
. CCP 6 indicates that U.S. product is to be stored below
(b)(4)
°C
after the
(b)(4)
step and prior to final product leaving factory; and final products in the refrigerated container must be set the temperature with below 4°C during the whole delivery. Your written response and CCP 6 also indicates that products would be packed into cartons on the same day and stored below
(b)(4)
°C, and that in special cases non-finished product will be stored in the refrigerated staging room below
(b)(4)
°C. Furthermore, you also provided monitoring records for non-finished product refrigerated storage (i.e., staging room) and final product refrigerated storage, and shipping documents showing that the shipping temperature is set to
(b)(4)
°C.
However, you did not provide a revised hazard analysis, and your updated HACCP plan for RTE vacuum packaged vegetables states that you will monitor the non-finished product at a frequency of “
(b)(4)
” and for final product at a frequency of “
(b)(4)
.” We note that the monitoring records you provided indicate that in fact, you are only monitoring the temperature of the non-finished product storage one time while product is being staged and one time while product is stored in the final product refrigerated storage. For example, your non-finished product refrigerated storage monitoring records indicate that lot #
(b)(4)
was placed in the non-finished product refrigerated storage on February 21, 2024 at
(b)(4)
(the monitoring record appears to identify this as the “
(b)(4)
”). The temperature of the non-finished product refrigerated storage at that time was documented to be
(b)(4)
°C. The product was removed from the non-finished product refrigerated storage on February 22, 2024 at
(b)(4)
(the monitoring record appears to identify this as the “
(b)(4)
”), at which time no temperature was recorded. Thereafter, the final product refrigerated storage monitoring record indicates that lot #
(b)(4)
, along with other lots, were placed in the final product refrigeration storage at
(b)(4)
on the same day (monitoring record appears to identify this as the “
(b)(4)
”). The temperature of the final product refrigerated storage at that time was documented to be
(b)(4)
°C. No other temperatures were documented on either monitoring record. Your monitoring procedures do not ensure control of proteolytic
C. botulinum
throughout the duration of refrigerated staging room and refrigerated final product storage. Since you are choosing to control
C. botulinum
through monitoring the temperature of the refrigerated storage, then you should continuously monitor the temperature (such as use of continuous recording device with a visual check of the recorded data at least once per day). In addition, we note that you must establish and implement corrective action procedures when your preventive controls are not properly implemented (see 21 CFR 117.150(a)(1).
The violation cited in this letter is 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 cause(s) of the violation identified above and for preventing its 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 correct or implement corrections to the violation cited in this letter.
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 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 regarding ready-to-eat human food products that are adulterated within the meaning of 402(a)(4) of the Act is Import Alert #99-43. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
Additionally, we offer the following comment:
According to your process flow description, seasoned bamboo product is cooled for
(b)(4)
minutes to a temperature below
(b)(4)
°C. Your hazard analysis does not identify the processing step of
(b)(4)
to control pathogenic bacterial growth and/or toxin formation as a biological hazard requiring a preventive control due to reduced oxygen packaging. Product should be cooled from 135°F (57°C) to 70°F (21°C) within two hours, and from 135°F (57°C) to 41°F (5°C) within six hours or less to control pathogenic bacterial growth and/or toxin formation.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking or have taken to correct the violation, including an explanation of each step being taken to prevent the recurrence of the violation, as well as providing copies of related documentation. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. 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 believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the U.S. Food and Drug Administration, Attention: Sheena Phillips, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration and Assessment Branch (HFS-607), 5001 Campus Drive, College Park, Maryland 20740 U.S.A. If you have any questions regarding this letter, you may contact Ms. Phillips via email at Sheena.Phillips@fda.hhs.gov. Please reference CMS # 681016 on any documents or records you provide to us and/or within the subject line of any email correspondence you send to us.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Content current as of:
07/16/2024
Regulated Product(s)
Food & Beverages