- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameSamson Wang
- Wan-Gee Foods, Inc.
10849 Midwest Industrial Blvd.
St. Louis, MO 63132
- Issuing Office:
- Division of Human and Animal Food Operations West II
November 9, 2023
CMS Case No.: 660360
Dear Mr. Wang:
The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility, located at 10849 Midwest Industrial Blvd. St. Louis, MO 63132 on May 2 through 24, 2023. This inspection covered your not ready-to-eat (nRTE) noodle products manufacturing operation. 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).
Based on FDA’s inspectional findings, we have determined the nRTE noodles products processed in your facility are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or 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)]. At the conclusion of the inspection, the FDA investigators issued an FDA Form 483 (FDA-483), Inspectional Observations. To date, you have not provided a response to the inspection. After reviewing the inspectional findings, we are issuing this letter to advise you of FDA’s concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (21 CFR Part 117, Subpart C):
1.You did not identify and evaluate a known or reasonably foreseeable hazard to determine whether it required a preventive control for your nRTE noodles products (i.e., wonton wrappers, egg roll wrappers, and noodles), as required by 21 CFR117.130(a)(1). Specifically,
a. You did not identify and evaluate the hazard of bacterial growth and/or toxin formation due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for your noodle products during production. The noodles are (b)(4). Therefore, bacterial growth and/or toxin formation due to lack of time/temperature control is a known or reasonably foreseeable hazard to be considered for these products. Staphylococcus aureus (S. aureus), a bacterial pathogen that can contaminate food via worker’s hands and skin, can grow and produce toxin if the noodle dough is subject to time/temperature abuse during production. The toxin is heat-stable and not easily destroyed by normal cooking temperatures. You do not know the water activity of the dough throughout drying, including whether and, if so, for how long it is above 0.85, which would support S.aureus growth and (potentially) toxin formation when the products are held at temperatures that support growth (e.g., 90°F) for sufficient time.
In addition, you did not identify and evaluate the hazard of bacterial growth and/or toxin formation due to lack of time/temperature control as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for your canton noodles during finished product storage. The canton noodles are treated as shelf stable, stored at ambient temperatures, and are not labeled to be kept refrigerated or frozen. You do not know the water activity of the finished product canton noodles, including whether it is above 0.85.
When responding to this letter, you should provide a revised hazard analysis showing that you identified and evaluated bacterial growth and/or toxin formation due to lack of time/temperature control. If you determine that S. aureus requires a preventive control, you should include a Food Safety Plan including a preventive control (e.g., a process preventive control for time/temperature control during dough production and canton noodle finished product storage) to address the hazard. The implementation of these corrective actions will be evaluated during our next inspection.
b. Mycotoxins – You did not identify and evaluate the hazard of mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control for your noodle products. The noodles contain wheat flour, which has been associated with mycotoxins such as deoxynivalenol (DON). Therefore, contamination with mycotoxins is a known or reasonably foreseeable hazard to be considered for these products. A knowledgeable person manufacturing/processing food in your circumstances would identify mycotoxins as a hazard requiring a preventive control(i.e., supply-chain control) in the wheat flour ingredient. Supply-chain controls include a supply-chain program as required by subpart G of 21 CFR part 117.
We note that you receive a Certificate of Analysis (COA) from your supplier of the wheat flour ingredient. However, the COA does not address mycotoxins. You stated that you do not have a supply-chain preventive control to address the hazard of mycotoxins in wheat flour.
On May 24, 2023, your Office Manager contacted your wheat flour supplier during the inspection and obtained a COA, which included an analysis for mycotoxins. However, you did not provide your revised hazard analysis showing that mycotoxins require a preventive control; you also did not provide a preventive control ensuring that mycotoxins would be controlled. In your response to this letter, you should include a Food Safety Plan including a supply-chain program covering mycotoxins in wheat flour used to make noodles. The implementation of these corrective actions will be evaluated during our next inspection.
2. You did not implement your preventive controls procedures to significantly minimize or prevent contamination with the hazard of metal in your nRTE noodle products as required by 21 CFR 117.135(a)(1).
In your food safety plan for wonton wrappers, egg roll wrappers, and noodles, you identified the hazard of metal as requiring a preventive control under the “Sanitation Preventive Controls” section at “Step 10-1: Package cut noodles into paper boxes,” and your plan requires “each box to pass through a metal detector to make sure it does not contain any metal debris.” Our investigators observed damage and missing pieces to your metal cutting blades used to shorten the dried noodles after the drying room step. The investigators requested monitoring records associated with the metal detector, but you did not provide them during the inspection.
Furthermore, your office manager stated you purchased a metal detector for the dried noodles, but it had not been calibrated and you do not perform daily verification checks. When asked how the metal detector is tested, a pair of scissors were sent through the machine. The office manager stated this was the first time the metal detector was checked, and she was not sure if the metal detector worked properly.
At the close of the inspection, your Office Manager promised to implement a standard operating procedure (SOP) for metals completed by August 1, 2023. In addition, she stated she ordered ferrous, non-ferrous, and stainless-steel wands to check the metal detector (b)(4). In addition, your Office Manager updated your “Metal Detector check off” sheet and began using it before the close of the current inspection. However, you did not provide your revised SOP for metals. You also stated you purchased new blades for the noodle cutting table and that they would be installed by July 1, 2023, but you have not provided any supporting documentation that this action had been completed. Furthermore, you stated you would have the metal detector calibrated by a third-party by August 1, 2023, but you have not provided supporting documentation demonstrating the calibration had occurred. In your response to this letter, you should provide your current SOP, calibration certificate, and other supporting documentation to demonstrate you have implemented your promised corrective actions. The adequacy of these corrective actions, and their implementation, will be verified during our next inspection.
3. Your written allergen preventive control does not include procedures, practices, and processes employed for labeling to ensure that all food allergens required to be stated are included on the label for your nRTE noodle products, as required by 21 CFR117.135(c)(2)(ii). Specifically,
In your food safety plan for wonton wrappers, egg roll wrappers, and noodles, you identified the hazard of undeclared allergens including wheat, egg, and soy at “Step 11:Pack paper boxes into bulk packaging and palletize.” At “Step 11” you state “final products must have ingredient label” under your Allergen Preventive Control and that you must “inspect final products regularly.” However, your procedure does not ensure all finished product labels declare all allergens present in the finished food to ensure finished food is not misbranded under section 403(w) of the Act (21 CFR 117.135(c)(2) because you do not document your review of finished product labels to ensure all allergens are properly declared. In addition, you told our investigators that you do not have a separate written allergen procedure aside from the procedure described in your Food Safety Plan above.
Furthermore, preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility's food safety system (see 21 CFR 117.140). You do not maintain any monitoring or corrective action records of your review of your product labels to ensure the allergen ingredients are listed on the label for each batch produced. The only record you maintain for production is your mixing log and it does not include are view of the allergen ingredients in the finished food against the packaging label.
At the conclusion of the inspection, you committed to creating documents for the label checks. However, you have not provided any supporting documentation demonstrating you have implemented the finished product label check. In your response to this letter, you should provide your revised written allergen procedures and completed allergen labeling monitoring records for at least five consecutive days of production as part of your response to this letter.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B):
1. You did not conduct operations under conditions and controls necessary to minimize the potential for contamination of food as required by 21 CFR 117.80(c)(2).
a. On May 2, 2023, during the production of canton noodles, lot number 05032023, in the Drying Room, where approximately (b)(4) of noodles are held each week, our investigators observed:
i. Apparent black mold formed on the ceiling directly over a drying canton noodle product in several locations throughout the room. The apparent mold covered approximately 30 percent of the ceiling. Further, the fans used to blow heated air ((b)(4) degrees Fahrenheit) directly onto the product to dry it were covered in approximately ¼ inch of apparent filth. In addition, the concrete floor along the walls in multiple locations throughout the drying room had what appeared to be white and greenish colored mold. The walls had apparent black mold in several different locations throughout the drying room.
ii. An employee hanging noodles on racks (b)(4). During our inspection, our investigators observed the two bins separate, causing an approximate 2-to-3-in. gap in between. This resulted in the bottom quarter of the noodles coming into contact with the floor.
During the inspection, your Office Manager instructed your operators to clean the walls, ceilings, and floors in the Drying Room. Afterwards, the apparent mold appeared to have been removed. However, the adequacy of this corrective action will be verified during our next inspection. At the conclusion of the inspection, you committed to replace the walls in the drying room by September 1, 2023. However, you did not provide any supporting documentation, such as an invoice or work order associated with this corrective action. You should provide documentation in your response to this letter that this corrective action has been completed or is underway. You also committed to creating a sanitation procedure to perform a (b)(4) dry clean in the drying room (b)(4), additional (b)(4) cleaning on (b)(4), and to clean the fans (b)(4). You should provide documentation that these corrections have been done. You also committed to purchasing a bigger bucket for the noodle product coming out of the extruder by July 1, 2023. You have not provided any supporting documentation demonstrating this correction has occurred.
b. On May 2, 2023, our investigators observed heavily beaded condensation formed over and falling onto boxed wonton wrappers, lot number 05021168, in the blast storage freezer. Our investigators also observed condensation falling onto packaged finished product. Although the product is wrapped in wax paper, the packaging is made of thin cardboard that is not sealed and the product is susceptible to contamination while it is held overnight in the blast freezer. Our investigators observed ice formed in several other locations in the freezer, including the floor, freezer units, and walls.
At the conclusion of the inspection, you committed to having the refrigerator/freezer fixed by August 1, 2023, but you did not provide any supporting documentation such as a work order or invoice or photographs that this repair is underway or completed. You should provide supporting documentation in your response to this letter.
c. On May 4, 2023, during the production of wonton wrappers, lot number 05040168, in the Production Room, our investigators observed:
i. The (b)(4) on the approximately (b)(4) was missing in several places throughout the tray. In addition, brittle plastic in several areas on the tray was broken and/or frayed. (b)(4) trays being used in production were in similar condition.
ii. Foam was present on the underside of the (b)(4) that comes indirect contact with the top layer of the wrappers during cutting. The foam is porous and not easily cleanable. Our investigators observed deteriorating foam on (b)(4) blade presses ((b)(4) egg roll and (b)(4) wonton), and parts of the foam were missing in several areas around the edges.
At the conclusion of the inspection, you committed to scheduling a technician to service the wonton and spring roll wrapper machine to adjust the cutting depth, purchase new trays, and discontinue the use of foam on the bottom of the blades. Although you provided a timeline for these corrective actions to take place, you have not provided any supporting documentation that these actions are underway or completed. You should provide this information in your response to this letter.
2. You did not take reasonable measures and precautions to ensure all persons working in direct contact with food, food-contact surfaces, and food-packaging materials conform to hygienic practices while on duty to the extent necessary to protect again contamination of food, as required by 21 CFR 117.10(b). Specifically, on May 2, 2023, five out of ten employees were observed in street clothes covered in apparent filth while handling dough used to manufacture wonton wrappers, lot 05040168, and canton noodles, lot 05032023. The employees’ clothes were in direct contact with the dough multiple times during manufacturing. For example, an employee was observed leaning directly on raw dough during the rolling process. Another employee was observed hanging the in-process canton noodles on the drying rack where the noodles would swing and brush against the employee’s clothes and bare skin. This is a repeat observation from our previous inspection which ended on May 13, 2022.
Our investigators asked the Office Manager if the employees had any type of cleaned outer garment for employees to wear during manufacturing. She stated that all employees should be wearing cleaned outer garments. Your office manager previously committed to ensuring employees would wear clean aprons during the production of the nRTE noodle products; however, this was not observed during the current inspection until May 24, 2023. We will verify the adequacy of this corrective action during our next inspection.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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 and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to the following address: U.S. Food and Drug Administration, 8050 Marshall Drive, Suite 205, Lenexa, Kansas 66214, to the attention of Danial S. Hutchison, Compliance Officer. If you need additional information or have questions concerning any products distributed through your website, please contact CO Hutchison (913)495-5154 or at the above address or via email at: Danial.Hutchison@fda.hhs.gov.
Dr. LaTonya M. Mitchell
Program Division Director
Office of Human and Animal Food