- Delivery Method:
- VIA UPS
- Food & Beverages
Recipient NameHyo Young Lee
- Happy Sprout Inc.
7954 Twist Lane, Unit H
Springfield, VA 22153-2823
- Issuing Office:
- Division of Human and Animal Food Operations East II
October 27, 2022
Dear Ms. Lee,
The U.S. Food and Drug Administration (FDA) inspected your sprouting operation, located at 7954 Twist Lane, Unit H, Springfield, Virginia from May 23-26, 2022, and on July 8, 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 112).
Based on our inspectional findings, we have determined that your mung bean and soybean sprout products 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. 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 FDA’s homepage at http://www.fda.gov.
The inspection resulted in the issuance of a Form FDA 483, Inspectional Observations, listing the violations found at your sprouting operation during our inspection. We acknowledge receipt of your response dated July 20, 2022, to the Form FDA 483. We address your response below.
Produce Safety Rule Violations
During the inspection, FDA investigators observed the following significant violations of the PSR, 21 CFR 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, or holding environment in accordance with the requirements of 21 CFR 112.145. You told the FDA investigator that you have not established such a written plan and that you have not tested the sprout growing, harvesting, packing, and holding environment for Listeria species or Listeria monocytogenes since October 2021. The cleaning and sanitizing methods that you use are not adequate to control Listeria species, as evidenced by FDA findings of Listeria species (not monocytogenes) in seven (7) environmental swabs collected during the inspection and a finished product sample collected from a retail location. This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019.
In your response, you state that you will collect environmental samples, have a digital monitoring log, and perform environmental monitoring. However, we cannot evaluate the adequacy of your corrective actions because you did not include the procedure or plan, or outline a timeframe in when you will implement these actions.
2. 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). You stated that you do not sample SSIW or in-process sprouts and that you were unsure if your sprouting operation has ever tested SSIW or in-process sprouts for any pathogen, including Escherichia coli O157:H7 or Salmonella spp. This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019.
In your response, you state that you will send your SSIW for Salmonella spp. and E. coli testing. However, we cannot evaluate the adequacy of your corrective actions because you did not include the testing plan or evidence that you have implemented it.
3. You did not 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). On May 23, 2022, investigators observed your sanitation practices after packaging ready-to-eat soybean sprouts. You did not apply sanitizer solution on any food contact surface. Instead, your employees rinsed equipment with water and (b)(4). Investigators observed your firm packing mung bean sprouts on May 24, 2022, without applying sanitizer prior to packing the sprouts. In addition, when an employee was asked about the frequency of sanitation activities, the employee stated that sanitizer is applied, “(b)(4).” Your General Manager also stated that while (b)(4) cleaning is conducted (b)(4), the (b)(4) is deep cleaned and sanitized (b)(4). Investigators observed, and your General Manager stated, that your firm operates (b)(4). This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019.
In your response, you indicate that you will change your cleaning procedures and revise your Sanitation Standard Operating Procedure (SSOP). You also indicated that you are sanitizing (b)(4). However, we cannot evaluate the adequacy of your corrective actions because your response did not include specific procedures or evidence to permit us to assess your corrections.
4. You did not train personnel who handle (contact) covered produce or food contact surfaces, as required by 21 CFR 112.21, and personnel who conduct covered activities or who supervise personnel who handle covered produce or food contact surfaces as required by 21 CFR 112.22. For example, farm management stated that employees were trained approximately ten (10) years ago. The timeframe of (b)(4) for employee training does not meet the requirement of at least once annually, as required by 21 CFR 112.21(a). In addition, training must be conducted in a manner that is easily understood by the personnel being trained (21 CFR 112.21(c)). Your employees stated that (b)(4). Your supervisor did not demonstrate a means to communicate with employees in order to correct their food handling practices. Further, farm management stated that they have not successfully completed a food safety training at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA, as required by 21 CFR 112.22(c). This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019.
In your response, you state that your General Manager will attend a future (b)(4) training when it is available. However, we cannot evaluate the adequacy of this corrective action because you did not give us evidence of the date of training, topics covered, the person(s) trained, or evidence the training was conducted in a manner easily understood by the personnel being trained. You also state that you will employ a (b)(4) to assist with written and verbal communication between firm management and employees. We cannot evaluate the adequacy of this corrective action because you have not provided evidence of its implementation or a timeframe in which you will implement it.
5. Personnel at your firm did not use hygienic practices, as required by 21 CFR 112.32. Specifically:
- On May 23 and 24, 2022, four (4) employees handled sprouts without first washing their hands before donning single-use gloves when returning from break or handled sprouts when gloves may have been soiled.
- On May 24, 2022, employees handled the bottom of a bin kept on the floor and then handled sprouts without washing their hands or changing gloves.
- On May 24, 2022, a gloved employee picked up a hose lying on the floor, used the hose, and then rinsed their gloved hands with only water in the production room hand sink before returning to the production line to skim mung bean sprout particles from the production line water bath.
- On May 23, 2022, two employees were packaging sprouts wearing watches that were not covered by their gloves or clothing. An employee was wearing a dangling necklace while packaging sprouts.
This deviation from the PSR was observed during a previous inspection of your firm conducted October 2-10, 2019.
In your response, you state that employees will be retrained and that you will make a conscious effort to ensure compliance. However, we cannot evaluate the adequacy of this corrective action because you did not provide evidence that you have retrained your employees on hygienic practices.
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 with an opportunity to address them. Failure to adequately address this matter may result in legal action by the FDA without further notice, including, without limitation, seizure and/or injunction.
Please notify FDA in writing, within fifteen (15) working days of the receipt of this letter, of the specific steps that 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 action 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
Please send your reply to Compliance Officer Andrew J. Howard at United States Food & Drug Administration, 11155 Dolfield Boulevard, Suite 117, Owings Mills, Maryland 21117. An emailed response is also acceptable. Files greater than 100 megabytes may be submitted as smaller files in separate emails. If you have questions regarding this letter, please contact CO Howard by telephone at (410) 779-5125, or by email at Andrew.Howard@fda.hhs.gov.
Randy F. Pack District
Director/Program Division Director