- Delivery Method:
- Via Express Delivery
- Food & Beverages
Recipient NameMr. Ren Hongjiang
- Panjin Hetian Food Co., Ltd.
Haba Village, Ping’an Town
Liaoning Sheng, 124207
- Issuing Office:
- Center for Food Safety and Applied Nutrition
July 7, 2021
Dear Mr. Ren Hongjiang:
The United States Food and Drug Administration (FDA) conducted an inspection of your rice protein powder facility, located at Haba Village, Ping’an Town, Dawa County, Panjin, Liaoning, China on December 1 to 3, 2020. During that inspection, the FDA investigator 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, listing the deviations found at your firm.
During our inspection of your facility, 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). The 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 emailed to us on December 21, 2020, which included a description of your corrective actions, corrective action record, training records, hygiene and sanitation standard operating procedures, swabbing procedure and test records, and photographs of corrections. 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 concerns and provide detailed information describing the findings at your facility.
Hazard Analysis and Risk-Based Preventive Controls (Subpart C):
Your hazard analysis for ready-to-eat (RTE) rice protein powder manufactured/processed at your facility did not identify and evaluate all known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control, as required by 21 CFR § 117.130(a). Specifically:
You did not identify contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for RTE rice protein powder. A hazard evaluation must include an evaluation of environmental pathogens whenever a RTE food is exposed to the environment prior to packaging and the packaged food does not receive a treatment or otherwise include a control measure (21 CFR 117.130(c)(1)(ii)). Your facility manufactures rice protein, a RTE food which is exposed to the environment after a (b)(4) treatment prior to packaging. Once packaged, the food does not receive a lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen or control by the supply chain or a downstream customer) that would significantly minimize the pathogen. In particular, you manufacture rice into a rice protein powder that is exposed to the environment at the (b)(4) steps. This exposure presents the potential for the rice protein powder to be contaminated with environmental pathogens, which can enter the facility in several ways, including on raw materials.
Note that if environmental pathogens are a hazard requiring a preventive control (i.e., sanitation controls, as required by 21 CFR 117.135(c)(3)), the controls must be verified by environmental monitoring (e.g., for environmental pathogen or an appropriate indicator organism as required by 21 CFR 117.165(a)(3)). Also note that your environmental monitoring procedures are inadequate to identify the presence of environmental pathogens or an appropriate indicator organism because TPC and coliforms are not indictor organisms for environmental pathogens.
The cleaning of food-contact surfaces at the ball grinding, vibrating, and packaging machines involves a cold water wash without detergent, followed by air drying. Your response indicates that your “(b)(4)” has been revised to include a colorless and odorless detergent when cleaning the ball grinders. However, it is not clear what equipment is included within the scope of your procedure or whether food-contact surfaces are sanitized after being cleaned. Water in a dry processing environment presents a significant risk factor for Salmonella contamination because water allows for pathogen growth, significantly increasing the risk for contamination of RTE food. Dry cleaning techniques such as wiping, scraping, sweeping, brushing, vacuuming, blowing, etc. are preferable. Where dry cleaning of equipment and facilities is not possible, and wet cleaning is deemed essential due to a product contamination incident or elimination of allergens, care should be taken to minimize spread and ingress of water throughout the facility. When wet cleaning is used, it should be carefully controlled, and should include use of a sanitizer. Water usage should be limited to an absolute minimum and confined to a specific area, and thorough drying is essential to minimize growth of Salmonella which may be in the environment.
Your response did not include a revised food safety plan pertaining to the hazard of contamination with environmental pathogens such as Salmonella during processing.
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 protein 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 specific to foreign firms that are not in compliance with the CGMP & PC rule 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.
You did not identify contamination with bacterial pathogens such as Salmonella in your raw materials as a known or reasonably foreseeable hazard to determine whether it requires a preventive control for your RTE rice protein powder. The presence of bacterial pathogens such as Salmonella is a reasonably foreseeable hazard in many raw materials, in particular raw agricultural commodities, which can be contaminated in the growing environment. These raw materials should be evaluated for such hazards to determine whether they require a preventive control (e.g., a (b)(4) step). Your hazard analysis considers mold, but not bacterial pathogens, in your raw materials and you determined that mold does not require a preventive control. However, you have identified your (b)(4) successive steam dryers as a (b)(4) step and consider these to be a critical control point, with a critical limit of (b)(4)% moisture content in the protein powder when exiting the (b)(4) dryer. You record temperatures, moisture content and flow rate (b)(4); these parameters are appropriate to monitor the process. Note that it is the time and temperature of the process that achieves the kill of vegetative pathogens such as Salmonella; the low moisture content of the protein powders will prevent growth and toxin production by pathogenic sporeformers such as Bacillus cereus that will survive the (b)(4) treatment. Review of your firm’s (b)(4) chamber records on 12/01/2020 found that actual temperature values were not recorded during monitoring of the (b)(4) process. Specifically,
• Chamber one’s operational temperature range to achieve adequate drying is (b)(4)ºC. Temperature gauge one was observed to read (b)(4)ºC at 12:29 PM on 12/1/2020 by the FDA investigator, however the operator recorded (b)(4)°C on the monitoring record at 12:30 PM. Therefore, the value did not appear accurate and, based on the investigator’s observation, did not meet the operational range.
• Chamber two's operational temperature range to achieve adequate drying is (b)(4)ºC. Temperature gauge two was observed to not be functioning at 12:30 PM on 12/1/2020; however, the operator recorded (b)(4)ºC (the maximum upper limit on the gauge) on the monitoring form every (b)(4) from (b)(4) to (b)(4). Your firm confirmed that the gauge was broken but did not revise the previously recorded temperatures or take other corrective actions.
Your response indicates that you have calibrated your thermometers and trained staff. We will verify the implementation of your corrections during the next inspection.
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 #614617 on any submissions and on the subject line of any emails to us.
Michael W. Roosevelt
Office of Compliance
Center for Food Safety
and Applied Nutrition