The FDA report stated "Glass fragments can be introduced into food whenever processing involves the use of glass containers. Normal handling and packaging methods, especially mechanized methods, can result in breakage. Ingesting glass fragments can cause injury to the consumer. In particular, your (b)(4). You did not investigate the root cause or evaluate other potentially affected products as a result of this rejection. The subject lot was shipped to the U.S."
During the inspection, FDA noted, "we noted deficiencies regarding your control of the glass hazard using your (b)(4) machine procedures. Specifically, on September 26, 2022, the first day of the inspection, your (b)(4) machine ((b)(4)) failed to reject a sample container of your RTE Mandarin Orange in light syrup in a glass jar which contained glass fragments for the purpose of demonstrating a challenge test for your (b)(4) machine. Your firm placed glass fragments into two (b)(4) oz. glass jars of mandarin oranges in light syrup to demonstrate the working conditions of your (b)(4) machine. However, your (b)(4) machine failed to reject one of the two jars. Your employees proceeded to alter settings on your firm’s machine until the machine rejected both sample jars of product. Your Corporate Quality Assurance Director also stated that your (b)(4) machine ((b)(4)) had never been calibrated previous to this. This indicates that your (b)(4) machine procedures did not control the hazard of glass contamination."
As part of the Foreign Supplier Verification Program, the FSVP importer must conduct a hazard analysis as well, and as part of this, would also need to recognize glass as a potential hazard to be controlled by the supplier. With that recognition as a hazard requiring control, the FSVP importer would need to establish verification activities to ensure the supplier was indeed controlling the hazard.
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yichang-jiayuan-foodstuffs-co-ltd-655593-05052023
Yichang Jiayuan Foodstuffs Co., Ltd
MARCS-CMS 655593 — MAY 05, 2023
FDA Warning Letter
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/yichang-jiayuan-foodstuffs-co-ltd-655593-05052023
Yichang Jiayuan Foodstuffs Co., Ltd
MARCS-CMS 655593 — MAY 05, 2023
Recipient:
Yi Hui Huang
Owner
Yichang Jiayuan Foodstuffs Co., Ltd
10 Juxiang Avenue, Yaqueling Town
Yiling Qu Yichang Shi Hubei Sheng, 443113
China
yihui.huang@jy-group.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
May 5, 2023
WARNING LETTER
Reference #655593
Dear Mr. Huang:
The United States (U.S.) Food and Drug Administration (FDA) inspected your food manufacturing facility, located at No. 10 Juxiang Avenue, Yaqueling Town, Yiling District, Yichang, Hubei, China on September 26-28, 2022. The inspection covered your ready-to-eat (RTE) Mandarin Oranges in light syrup in glass jars. During our inspection, FDA investigators 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 deviations found at your facility.
Based on FDA’s inspectional findings, we have determined that the RTE Mandarin Oranges in light syrup in glass jars 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 United States Codes (U.S.C.) § 342(a)(4)] because they were 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. 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 further information about the CGMP & PC rule through links in FDA’s Internet home page at http://www.fda.gov.External Link Disclaimer
We received your response emailed to us on October 16, 2022, which included a description of your corrective actions and supporting documents including photos, revised procedures, monitoring records, training records, and calibration records. After reviewing the inspectional findings and your response to the observations listed in FDA Form 483, 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 117, Subpart C):
You did not appropriately evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR 117.130(a)(1). Specifically, your hazard analysis for mandarin orange in syrup products identified the physical hazard of glass chips, but you determined that this hazard does not require a preventive control.
Glass fragments can be introduced into food whenever processing involves the use of glass containers. Normal handling and packaging methods, especially mechanized methods, can result in breakage. Ingesting glass fragments can cause injury to the consumer. In particular, your (b)(4). You did not investigate the root cause or evaluate other potentially affected products as a result of this rejection. The subject lot was shipped to the U.S.
For the foregoing reasons, contamination with glass is a known or reasonably foreseeable hazard. Further, a knowledgeable person manufacturing/processing food in your circumstances would identify glass as a hazard requiring a preventive control (i.e., process controls) in your RTE Mandarin Oranges in light syrup in glass jars. Process controls include procedures, practices, and processes to ensure the control of parameters during operations (see 21 CFR 117.135(c)(1)). While you did identify the physical hazard of glass chips in your hazard analysis of the product at the (b)(4) step, you determined that this hazard did not require a preventive control because your firm (b)(4)
However, during the inspection, we noted deficiencies regarding your control of the glass hazard using your (b)(4) machine procedures. Specifically, on September 26, 2022, the first day of the inspection, your (b)(4) machine ((b)(4)) failed to reject a sample container of your RTE Mandarin Orange in light syrup in a glass jar which contained glass fragments for the purpose of demonstrating a challenge test for your (b)(4) machine. Your firm placed glass fragments into two (b)(4) oz. glass jars of mandarin oranges in light syrup to demonstrate the working conditions of your (b)(4) machine. However, your (b)(4) machine failed to reject one of the two jars. Your employees proceeded to alter settings on your firm’s machine until the machine rejected both sample jars of product. Your Corporate Quality Assurance Director also stated that your (b)(4) machine ((b)(4)) had never been calibrated previous to this. This indicates that your (b)(4) machine procedures did not control the hazard of glass contamination.
Your response indicates that after our inspection, the (b)(4) machine supplier calibrated your machine and trained your employees. We also note that you updated your procedures and monitoring forms. However, your response did not include a revised food safety plan to address your failure to identify a preventive control for the physical hazard of glass pieces. In addition, if you provide additional information and explanations, such as any other information regarding your (b)(4) machine (including accuracy and sensitivity specifications for detection of glass pieces, details pertaining to the pre-operational accuracy checks you are conducting and test pieces you have selected to ensure your machine is able to detect glass fragments in your product, and the type and size of standards being used during pre-operational checks), please note that information provided in English will facilitate our review.
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 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 correct or implement corrections to the violations cited in this letter.
Failure to adequately address this matter may lead to regulatory 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 appear to have been prepared, packed, or held under insanitary conditions is Import Alert #99-43. You may view this alert at: http://www.accessdata.fda.gov/cms_ia/ialist.html.
Please 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 these deviations, including an explanation of how your firm plans to prevent these violations 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.
Additional Comments:
We will verify the adequacy and ongoing implementation of your corrective actions for several other observations that were documented on the FDA Form 483. We also remind you that records must be kept as original records; contain actual values and observations obtained during monitoring and, as appropriate, during verification activities; and be created concurrently with performance of the activity documented (see 21 CFR 117.305).
You should direct your written reply to Marco Esteves, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-607), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Mr. Esteves via email at Marco.Esteves@fda.hhs.gov. Please reference #655593 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
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