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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.
Yichang Jiayuan Foodstuffs Co. Ltd
Yichang, Hubei, China
A food firm in China is on notice from the FDA for serious violations of U.S. regulations. Investigation let to the determination that the ready-to-eat (RTE) Mandarin Oranges in light syrup in glass jars manufactured in the firm’s facility are adulterated 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 a May 5, 2023, warning letter, the FDA described a Sept. 26-28, 2022, inspection of their food manufacturing facility in Yichang, Hubei, China.
The FDA’s inspection found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation and resulted in the issuance of an FDA Form 483.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR 117, Subpart C):
The firm did not appropriately evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Specifically, their hazard analysis for mandarin orange in syrup products identified the physical hazard of glass chips, but they 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, their (redacted). They 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 their circumstances would identify glass as a hazard requiring a preventive control (i.e., process controls) in their RTE Mandarin Oranges in light syrup in glass jars. Process controls include procedures, practices, and processes to ensure the control of parameters during operations. While they did identify the physical hazard of glass chips in their hazard analysis of the product at the (redacted) step, they determined that this hazard did not require a preventive control because their firm (redacted).
However, during the inspection, FDA noted deficiencies regarding their control of the glass hazard using their (redacted) machine procedures. Specifically, on Sept. 26, 2022, the first day of the inspection, their (redacted) machine (redacted) failed to reject a sample container of their RTE Mandarin Orange in light syrup in a glass jar that contained glass fragments for the purpose of demonstrating a challenge test for their (redacted) machine. Their firm placed glass fragments into two (redacted) ounce glass jars of mandarin oranges in light syrup to demonstrate the working conditions of their (redacted) machine. However, their (redacted) machine failed to reject one of the two jars. Their employees proceeded to alter settings on their firm’s machine until the machine rejected both sample jars of product. Their Corporate Quality Assurance Director also stated that their (redacted) machine (redacted) had never been calibrated previously to this. This indicates that their (redacted) machine procedures did not control the hazard of glass contamination.
The firm’s response indicates that after FDA inspection, the (redacted) machine supplier calibrated their machine and trained their employees. FDA also noted that they updated their procedures and monitoring forms. However, their response did not include a revised food safety plan to address their failure to identify a preventive control for the physical hazard of glass pieces. In addition, if they provide additional information and explanations, such as any other information regarding their (redacted) machine (including accuracy and sensitivity specifications for detection of glass pieces, details pertaining to the pre-operational accuracy checks they are conducting and test pieces they have selected to ensure their machine is able to detect glass fragments in their product, and the type and size of standards being used during pre-operational checks), please note that information provided in English will facilitate FDA review.
The full warning letter can be viewed here.
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