- Delivery Method:
- United Parcel Service
- Food & Beverages
Recipient NameEdwin R. Wong
- Sun Sen Co., Inc.
290 Commerce Circle
Sacramento, CA 95815
- Issuing Office:
- Office of Human and Animal Food Operations – West Division 5
Dear Mr. Wong:
The U.S. Food and Drug Administration (FDA) inspected your sprout growing, harvesting, packing, and distributing facility, located at 290 Commerce Circle, Sacramento, California, from March 28-30, 2022, and on April 11, 2022. Our inspection revealed serious violations of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption regulation (Produce Safety Regulation or PSR), Title 21, Code of Federal Regulations, Part 112 (21 CFR Part 112). Your operation is a farm mixed-type facility because your sprout growing operation is a farm, and you also conduct activities outside of the farm definition (i.e., storage and repacking of certain other food) (b)(3)(A). Your farm is subject to 21 CFR Part 112 and your facility is subject to 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 our inspectional findings, we have determined that your alfalfa and clover sprout products, and a combination thereof, are adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)], in that they have been 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 to comply with the PSR is a prohibited act under section 301(vv) of the Act [21 U.S.C. § 331(vv)]. You can find the Act and FDA regulations through links on the FDA’s home page at www.fda.gov.
We have not received your written response to the Form FDA 483, Inspectional Observations, issued to you at the close of the inspection on April 11, 2022.
Produce Safety Rule Violations
During the inspection, FDA investigators observed the following significant violations of the PSR, 21 CFR Part 112:
1. You did not establish and implement a written environmental monitoring plan that is designed to identify Listeria species or Listeria monocytogenes if it is present in the growing, harvesting, packing, and holding environment in accordance with the requirements of 21 CFR 112.145. On April 11, 2022, you told the FDA investigator that you have not established such a written plan and have never tested the sprout growing, harvesting, packing, and holding environment for Listeria species or Listeria monocytogenes. This deviation from the PSR was previously discussed with you during inspections conducted on July 26, 2018, and August 3, 2021. On April 11, 2022, at the conclusion of the current inspection, you stated your intent to create a written plan for environmental sampling and to contact an accredited lab to begin monitoring for Listeria species or Listeria monocytogenes in your sprout growing, processing, packaging, and holding areas. However, you have not provided any evidence in support of your proposed corrective actions.
2. You did not, at a minimum, take the actions listed in 21 CFR 112.146, after your growing, harvesting, packing, or holding environment tested positive for Listeria species or Listeria monocytogenes. On March 28, 2022, FDA investigators collected environmental samples. Analysis of these samples identified Listeria seeligeri in 1 of 102 environmental swabs (INV1177912, Sub 28). Sub 28 was collected from a joint surface between your metal sprout wash tank and metal exterior surface within your sprout growing room. On April 11, 2022, at the conclusion of the current inspection, you stated that you have covered the area with a non-porous plastic sheet protector and would perform additional cleaning of the area. You have not provided any evidence in support of your proposed corrective action. In addition, your proposed corrective action does not include additional testing of surfaces and surrounding areas, cleaning and sanitizing the affected surfaces, conducting additional sampling to determine whether Listeria seeligeri has been eliminated, and other actions necessary to prevent recurrence of the contamination as required by 21 CFR 112.146.
3. You did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens as specified in 21 CFR 112.147 and in accordance with 21 CFR 112.144(b). On April 11, 2022, you told our investigators that you have not collected and tested a SSIW sample, or in-process sprouts, since your involvement in a sprouting seed supplier recall in 2004. This deviation from the PSR was previously discussed with you during inspections conducted on July 26, 2018, and August 3, 2021. On April 11, 2022, at the conclusion of the current inspection, you stated that you will establish a written SSIW sampling plan and will contact an accredited lab to begin collecting an SSIW sample or in-process sprouts from each production batch of alfalfa and clover sprouts. However, you have not provided any evidence in support of your proposed actions.
4. You did not appropriately clean and sanitize food contact surfaces you use to grow, harvest, pack, or hold sprouts before contact with sprouts or seeds or beans used to grow sprouts as required by 21 CFR 112.143(b). During the most recent inspection, our investigators observed:
- Approximately ten unclean (b)(4) perforated bins used to hold in-process, washed, and RTE alfalfa and clover sprouts being stacked inside of one another.
- Four unclean metal mesh screens located inside the (b)(4) identified as “2 West”. On March 29, 2022, you stated this growing unit had been cleaned in accordance with the firm’s sanitation procedures. Following cleaning, your sprout production employee then placed alfalfa seeds (Lot #SAL2-20GJ) and clover crimson seeds (Lot #SCL2-21BJ) inside a (b)(4) identified as “(b)(4)” to be germinated and grown inside this unclean growing unit.
Your failure to clean and sanitize food contact surfaces in accordance with the PSR was previously discussed with you during the inspection conducted on August 3, 2021.
In addition, on March 28, 2022, you told our investigator that your method of cleaning and sanitizing consists of scrubbing and subsequently rinsing food-contact surfaces using an undiluted concentration of (b)(4). Your inadequate sanitation practices and use of a sanitizing agent in place of conducting cleaning activities were also discussed during the regulatory meeting held December 15, 2021.
5. You did not establish and keep documentation of the date and method of cleaning and sanitizing of equipment as required by 21 CFR 112.140(b)(1) and (b)(2). On March 28, 2022, you explained to FDA investigators that you did not establish and do not maintain documentation of the date and method of cleaning and sanitizing of food contact equipment and tools used in the growing, harvesting, processing, and packing of alfalfa and clover sprouts. This deviation from the PSR was previously discussed with you during inspections conducted on July 26, 2018, and August 3, 2021.
6. Personnel at your firm did not use hygienic practices listed in 21 CFR 112.32. On March 28 and 29, 2022, FDA investigators observed employees touching non-food contact surfaces, including personal clothing, a cellphone, the south end cold storage room plastic strip curtain, and a pallet jack. The same employees were then observed harvesting, washing, and packing alfalfa and clover sprouts without changing their gloves or washing their hands. On April 11, 2022, at the conclusion of the current inspection, you stated that you will implement an employee training program. However, you have not provided any evidence in support of your proposed corrective action.
7. You did not appropriately train personnel who handle (contact) covered produce or food contact surfaces, and personnel who conduct covered activities, as required by 21 CFR 112.21 and 21 CFR 112.22, respectively. You stated that you have not successfully completed a food safety training at least equivalent to what is received under standardized curriculum recognized as adequate by the U.S. Food and Drug Administration (21 CFR 112.22(c)). In addition, you stated that you currently have (b)(4) full-time and (b)(4) part-time employees who did not receive any training upon hire, or any training since. On April 11, 2022, at the conclusion of the current inspection, you stated that you will implement an employee training program. However, you have not provided any evidence in support of this proposed corrective action.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations 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.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any 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 actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written response should be sent electronically to:
Hardcopy response can be sent to:
Sergio Chavez, Director, Compliance Branch
Food and Drug Administration
Office of Human and Animal Foods Division West 5
1201 Harbor Bay Parkway
Alameda, CA 94502
Refer to Unique Identification Number CMS# 631981 when replying.
If you have any questions regarding this letter, please contact Kimberly M. Lichter, Compliance Officer, at Kimberly.Lichter@fda.hhs.gov or (949) 608-2967.
Darla R. Bracy
District Director | FDA San Francisco District
Program Division Director
Office of Human and Animal Food Operations – West Division 5