This is a great demonstration for the need of a tight Supplier Preventive Control as part of the Preventive Controls for Human Foods OR as part of a FSVP. Note the issue with Certificates of Analysis (COAs). A good reason to always verify COA with one's own testing. This is especially important since this is considered a RTE ingredient.
Issues included:
Pingdingshan Tianjing Plant Albumen Co., Ltd.
MARCS-CMS 675567 — APRIL 17, 2024
Issues included:
- 'The hazard analysis covering the RTE Soy Protein Isolate did not identify the hazard of recontamination with environmental pathogens (e.g., Salmonella) as requiring a preventive control.'
- 'Further, after employees completed and documented cleaning of the packing room, the investigator visually observed apparent soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes. The also visually observed soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes.'
- 'The production manager also informed the investigator that the only method of sanitization for the equipment in the packaging room is turning on the ceiling-mounted ultraviolet light for (b)(4) minutes before starting packaging. Of course, the company must ensure that the sanitization system is effective in reducing environmental pathogens on food-contact packaging surfaces to a safe level (including those far from the light source, those where the light might not reach, and those with organic residues.)'
- The firm did not take effective measures to exclude pests from the processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, including a live insect was observed crawling inside the facility’s post-heat treatment packaging room for the RTE soy protein products; three live crawling insects and two dead insects were observed on the floor of the spray dryer room, which is directly adjacent and connected to the post-heat treatment packaging room; and a gap was observed at the bottom of the packaging room entry doors.
- Failed to properly store equipment, remove litter and waste, and cut weeds and grass within the immediate vicinity of the plant thus constituting an attractant, breeding place, or harborage for pests, as required by 21 CFR 117.20(a)(1). Specifically, the exterior ground along the south side of the facility was overgrown with weeds and being used as a storage area for scrap metal and old equipment. This area is directly outside the soy packaging room.
- The firm provided the investigator with certificates of analysis (COAs) for outgoing shipments of Soy Protein Isolate to U.S. customers which included results for Salmonella and E. coli testing. However, the firm had no original testing data to support the results on the COA. According to the Laboratory Manager and Food Safety Plan Systems manager, the firm sends their U.S. customers COAs with data that is not supported by actual results but creates the COA with values to satisfy the customer specifications. The firm then performs testing after the batches are sent to the U.S.; however, the testing does not include Salmonella or E. coli.
Pingdingshan Tianjing Plant Albumen Co., Ltd.
MARCS-CMS 675567 — APRIL 17, 2024
Recipient:
Mr. Yan Wang
President
Pingdingshan Tianjing Plant Albumen Co., Ltd.
South of Yancheng East Road
Ye Xian Pingdingshan Shi Henan Sheng, 467200
China
coral@tjprotein.com
ISP@tjprotein.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
April 17,2024
Reference # 675567
Dear Mr. Yan Wang:
The United States (U.S.) Food and Drug Administration (FDA) inspected your food manufacturing facility, located at South of Yancheng East Road, Ye County, Pingdingshan, Henan, 467200, China from August 15 to 17, 2023. The inspection covered your ready-to-eat (RTE) Soy Protein Isolate. During our 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 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 Soy Protein Isolate manufactured in your facility is 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 it was prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or whereby it 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.
We received your response to the FDA Form 483 emailed to us on August 31, 2023, which included a description of your corrective actions and supporting documents including translations of your revised sanitation procedures, environmental monitoring procedure, and photos of corrections. After reviewing the inspectional findings and your responses, we are issuing this letter to advise you of FDA’s continuing concerns and to 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 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 covering in your RTE Soy Protein Isolate did not identify the hazard of recontamination with environmental pathogens (e.g., Salmonella) as requiring a preventive control. Your hazard analysis included within you HACCP plan collected during the inspection indicates that sanitation is managed through a pre-requisite program which states that packing personnel operate according to standard operating procedures. However, your facility manufactures RTE Soy Protein Isolate which is exposed to the environment after your “(b)(4)” step prior to packaging. Your employees hand-pack the Soy Protein Isolate using a scoop and the packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in your circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control (i.e., sanitation controls). Thus, your hazard analysis should have concluded that environmental pathogens such as Salmonella are a hazard requiring a preventive control (i.e., sanitation controls; see 21 CFR 117.135(c)(3)). Sanitation 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, after employees completed and documented cleaning of the packing room, the investigator visually observed apparent soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes.
Additionally, your production manager informed the investigator that you use a vacuum for cleaning your post-lethal treatment direct food-contact surfaces in your packaging room. However, after employees completed and documented cleaning, the investigator visually observed soy protein powder residue on food-contact surfaces including the manual hand scoop, powder filling spout, and air removal probes. Your production manager also informed the investigator that the only method of sanitization for the equipment in the packaging room is turning on the ceiling-mounted ultraviolet light for (b)(4) minutes before starting packaging. You should ensure that your sanitization system is effective in reducing environmental pathogens on food-contact packaging surfaces to a safe level (including those far from the light source, those where the light might not reach, and those with organic residues.)
Also, you have a written environmental monitoring program which includes weekly equipment swabs, employee hand swabs, and air samples collected for total plate count, coliforms, and “pathogenic bacteria”, which your Laboratory Manager stated was for Salmonella. However, you did not have any documentation that environmental swabs were ever tested for Salmonella or an appropriate indicator organism. Further, your written environmental monitoring procedure does not identify the test microorganism(s), test method(s), laboratory conducting the testing, or corrective action procedures that include describing the steps to be taken to ensure that the appropriate action is taken to (i) identify and correct the problem; (ii) reduce the likelihood of reoccurrence; (iii) evaluate all affected food for safety; and (iv) prevent affected food from entering commerce, as required by 21 CFR 117.165(b)(3) and 117.150(a)(2).
Your response included photos of cleaned equipment and a translated description of your revised sanitation procedures which now involve using compressed air to clean the dual air removal probes, manual scoop and other food-contact equipment. Additionally, your response stated that your revised procedures include using a special vacuum cleaner to ensure there is no dust on the ground, upper part of equipment or pipelines and disinfecting food-contact equipment such as automatic packaging machines, dual air removal probes and the stainless-steel scoop with alcohol. However, it is not clear how frequently food-contact surfaces will be cleaned and sanitized.
Your response also included a revised environmental monitoring procedure which now includes testing for Salmonella using a “(b)(4) method.” However, it is not clear what method you are using for Salmonella testing.
The revised environmental monitoring procedure in your response also included a corrective action procedure. It indicates that “When foreign matters (include insects) are found in the packaging room, production should be immediately stopped. Disinfect and sterilize foreign matters.” However, it is not clear how your corrective actions apply to positive results for Salmonella.
Finally, your response also did not indicate whether you have identified a preventive control for the hazard of recontamination with environmental pathogens where RTE Soy Protein Isolate is exposed to the environment.
Current Good Manufacturing Practice (21 CFR Part 117, Subpart B)
2. You did not take effective measures to exclude pests from your processing, packing, and holding areas and to protect against the contamination of food on the premises by pests, as required by 21 CFR 117.35(c). Specifically:
i. A live insect was observed crawling inside your facility’s post-heat treatment packaging room for your RTE soy protein products.
ii. Three live crawling insects and two dead insects were observed on the floor of your spray dryer room, which is directly adjacent and connected to your post-heat treatment packaging room.
iii. A gap was observed at the bottom of the packaging room entry doors.
Your response included a photo of the gap at the bottom being sealed and your new procedure to stop production and disinfect whenever insects are found in the packaging room. However, your response did not provide information regarding pest control activities and monitoring within your facility.
3. You failed to properly store equipment, remove litter and waste, and cut weeds and grass within the immediate vicinity of your plant that may constitute an attractant, breeding place, or harborage for pests, as required by 21 CFR 117.20(a)(1). Specifically, the exterior ground along the south side of your facility was overgrown with weeds and being used as a storage area for scrap metal and old equipment. This area is directly outside your soy packaging room.
Your response included photos of the exterior grounds of your facility which show that they have been cleared of the old equipment and trimming of weeds. We will evaluate the maintenance of your exterior grounds during the next inspection.
The violations 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: Import Alert 99-43 (fda.gov).
Additional Comments:
During the inspection, your firm provided the investigator with certificates of analysis (COAs) for outgoing shipments of Soy Protein Isolate to U.S. customers which included results for Salmonella and E. coli testing. However, your firm had no original testing data to support the results on the COA. According to your Laboratory Manager and Food Safety Plan Systems manager, your firm sends their U.S. customers COAs with data that is not supported by actual results but creates the COA with values to satisfy the customer specifications. Your firm then performs testing after the batches are sent to the U.S.; however, the testing does not include Salmonella or E. coli.
Your response indicates that your firm has since tested stored samples of the batches shipped to the U.S. for Salmonella and E.coli. In addition, you indicate that you will revise future COAs to reflect testing for Coliforms instead of E.coli and that you have added Salmonella and Staphylococcus aureus testing. However, your response does not indicate whether you have changed your practice of providing your customer with COA results before testing is completed. Your response also does not indicate whether you have updated your U.S. customers regarding the erroneous information provided in the original COAs.
Records must be kept as original records, contain the actual values and observations obtained during monitoring and as appropriate during verification activities, be accurate, be created concurrently with the performance of the activity documented and be as detailed as necessary to provide history of the work performed, as required by 21 CFR 117.305.
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 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.
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 #675567 on any submissions and on the subject line of any emails to us.
Sincerely,
/S/
Ann M. Oxenham, J.D.
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
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