WARNING LETTER
Guangzhou Sinocon Food Co., Ltd
MARCS-CMS 692652 —
December 23, 2024
Delivery Method:
Via Express Delivery and Electronic Mail
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Zhuhui Xu
Recipient Title
General Manager
Guangzhou Sinocon Food Co., Ltd
No. 238 Zheng'Ao Road
Aotou Town
Conghua Qu
Guangzhou Shi
Guangdong Sheng
,
510900
China
gm@sinoconfood.com
Issuing Office:
Human Foods Program
United States
December 23, 2024
WARNING LETTER
Re: CMS # 692652
Dear Mr. Xu:
The United States (U.S.) Food and Drug Administration (FDA) conducted an inspection of your food manufacturing facility, located at No. 238 Zheng'Ao Road, Aotou Town, Conghua, Guangzhou, 510900, Guangdong, China, on March 18-19, 2024. The inspection covered your ready-to-eat (RTE) Oat Beta Glucan powder. During the inspection, our FDA investigator found a serious violation 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 an FDA Form 483, Inspectional Observations (FDA Form 483), listing the violation found at your facility.
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 can find the Act and applicable regulations through links on FDA’s Internet home page at www.fda.gov.
We received your written responses to the FDA Form 483, sent through email on April 3, June 26, 27, and 28, 2024. Your responses included descriptions of your corrective actions and supporting documentation, including updated environmental monitoring procedures. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continuing concerns and provide detailed information describing the findings at your facility. We also address your responses below.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1. You did not appropriately 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 Oat Beta Glucan Production Process hazard analysis, dated July 9, 2022, did not consider recontamination with environmental pathogens at the
(b)(4)
step(s) to evaluate whether it requires a preventive control. Further, although your hazard analysis identified the potential biological food safety hazards of “salmonella, staphylococcus aureus, and coliforms” at the
(b)(4)
step, it did not identify them as hazards requiring a preventive control. The
(b)(4)
step is performed after sterilization, and involves the combining of multiple production lots of sterilized product over several days. Product is exposed to the environment at the
(b)(4)
steps, and does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize pathogens. A knowledgeable person manufacturing/ processing food in your circumstances would identify recontamination with environmental pathogens as requiring a preventive control (i.e. sanitation controls). Thus, your hazard analysis should have concluded that recontamination with environmental pathogens, such as
Salmonella
, was a hazard requiring a preventive control. Preventive controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens (see 21 CFR 117.135(c)(3)).
Furthermore, your Research and Development Manager stated that, for lots of Oat Beta Glucan (including lots SF-OG70-240227, SF-OG70-240203, and SF-OG70-240122), you create and provide to customers finished product Certificates of Analysis (COAs) in English indicating that the lots tested negative for the pathogens of
Salmonella
and
S. aureus
, even if the product lots have not actually been tested for these pathogens. As required by 21 CFR 117.305(b) and (d), records must be accurate, and be created concurrently with performance of the activity documented.
Finally, when contamination with environmental pathogens is a hazard requiring a prevention control, you must verify the effectiveness of this preventive control by performing environmental monitoring for an environmental pathogen or for an appropriate indicator organism, if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control, by collecting and testing environmental samples (see 21 CFR 117.165(a)(3)). During the inspection, you identified that you conduct environmental monitoring of the packaging room for total plate count, yeast and mold, and
E. coli
; however, you do not conduct environmental monitoring for
Salmonella
or an appropriate indicator organism.
In your document titled “
(b)(4)
”, submitted with your email received April 3, 2024, you indicate that you have improved your Hazards Control Plan, created an Environmental Surveillance Plan for pathogens (including
Salmonella
), provided training for staff, and will test Salmonella for all Oat Beta Glucan sold, or to be sold, to the U.S, and that you will review cleaning methods and evaluate the feasibility of combining vacuuming, dry towel wiping, and alcohol cleaning. In your email received June 26, 2024, you also provide supporting documentation, including a document titled “
(b)(4)
”, which identifies controls for the biological hazard of
Salmonella
at the
(b)(4)
(i.e.,
(b)(4)
) stage, including “
(b)(4)
” of “
(b)(4)
[finished product] test reports.” Also, you indicate that products intending to be “sold to USA are tested for
(b)(4)
”, “
(b)(4)
”, and conducting “
(b)(4)
”. However, your responses do not include an updated Hazard Analysis or indicate whether you have determined that recontamination with environmental pathogens is a hazard requiring a preventive control at your
(b)(4)
processing steps.
Further, although your June 26, 2024, response indicates that finished product testing for
Salmonella
will be conducted for each batch of product(s) intending to be sold to the U.S., your response does not indicate that you have changed your practice sufficiently so that none of your products that are consumed in the U.S. are accompanied by COAs inaccurately reporting negative
Salmonella
test results. It is also unclear whether you have changed your practice regarding COAs for S. aureus test results so that inaccurate COAs are not associated with your food for consumption in the U.S. Further, your response does not indicate whether you have notified, or plan to notify, customers regarding the negative
Salmonella
and
S. aureus
testing information provided in your original COAs, when testing was not performed.
In addition to your “
(b)(4)
”, you also provide documents titled “
(b)(4)
” and “
(b)(4)
” in your response email received June 26, 2024, identifying that you have begun conducting environmental monitoring for
salmonella
. However, your monitoring program does not identify the analytical tests to be conducted, including analytical methods used, as required by 21 CFR 117.165(b)(3)(v).
The violation 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 cause 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. Failure to adequately address this matter may lead to regulatory action.
In addition to the above violation, we also offer the following comment:
You identified to our Investigator that your cleaning program for the mixing equipment and surrounding clean room includes a wipe down of the equipment with a dry towel, followed by vacuuming, and a rinse with clean water. Your Research and Development and Factory Manager also identified water without soap is used to rinse mixing equipment after the production of Oat Bran (a product produced on mixing equipment shared with Oat Beta Glucan). Introduction of large amounts of water to clean equipment in a low-moisture food environment can create a moist environment that can support the growth of environmental pathogens such as
Salmonella
.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response to this letter should outline the specific steps you are taking or have taken to correct these deviations, including an explanation of how your firm plans to prevent this violation or similar violations from occurring again. More specifically, your response should include documentation of the corrective actions your firm has taken. 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 your firm’s planned corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen (15) business days, state the reason for the delay and the time within which these activities will be completed.
Please send your reply to the Food and Drug Administration via email to HFP-OCE-ConventionalFoods@fda. hhs.gov. If sending a response by mail, address to Food and Drug Administration Human Foods Program – Office of Compliance and Enforcement, Office of Enforcement – Division of Conventional Foods (HFS-607), 5001 Campus Drive, College Park, MD 20740 U.S.A. If you have any questions regarding any issues in this letter, please contact HFP-OCE-ConventionalFoods@fda.hhs.gov, and include reference CMS # 692652 on any submissions and within the subject line of any correspondences to us.
Sincerely,
/S/
Maria S. Knirk, JD MBA
Acting Director, Office of Enforcement
Office of Compliance and Enforcement
Human Foods Program
Content current as of:
12/31/2024
Regulated Product(s)
Food & Beverages