WARNING LETTER
St. Louis Calco, LLC
MARCS-CMS 669917 —
March 21, 2024
Delivery Method:
VIA UPS
Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Xiaohui Zhou
Recipient Title
Owner
St. Louis Calco, LLC
1336 W. Lark Industrial Dr.
Fenton
,
MO
63026-4323
United States
Issuing Office:
Division of Human and Animal Food Operations West II
United States
WARNING LETTER
March 21, 2024
CMS Case# 669917
Dear Mr. Zhou:
The U.S. Food and Drug Administration (FDA) inspected your sprout operation, located at 1336 W. Lark Industrial Drive, Fenton, MO from September 18-22, 2023, and on September 29, 2023. 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).
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. 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.
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 received your written responses dated October 10, October 19, October 20, and October 24, 2023, which describe your completed and planned corrective actions to the Form FDA 483. We address your responses below.
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 (L. monocytogenes)
if it is present in your growing, harvesting, packing, and holding environment in accordance with the requirements of 21 CFR 112.145. This deviation from the PSR was also observed during a previous inspection of your firm conducted from September 16-18, 2019.
Your employee stated you do not have a written plan for environmental monitoring for Listeria, nor have you ever conducted environmental testing for Listeria species or L. monocytogenes. On September 20, 2023, FDA investigators collected environmental samples. Analysis of these samples identified L. monocytogenes in 4 of 102 environmental swabs, including from swabs taken from food contact surfaces. L. monocytogenes is a pathogenic bacterium that is widespread in the environment and may be introduced into a sprouting operation from raw materials, humans, or equipment. Without proper sanitation practices, it can proliferate in a sprouting operation where it may contaminate food.
In your written corrective action plan dated October 20, 2023, you state that you will begin to perform environmental monitoring once you have hired a consultant who can provide guidance on environmental monitoring and put your procedure in writing once it is established. In addition, in your email response dated October 10, 2023, you provided photographs to show that you collected
(b)(4)
environmental swabs in and on locations around your sprout pool near where FDA detected
L. monocytogenes
. You also provided analytical results showing all swabs tested negative. However, during a telephone call held with you on October 16, 2023, you explained you took those samples immediately after you cleaned the sprouts pool with
(b)(4)
and sanitized it with a
(b)(4)
solution. During that October 16th, 2023, call, FDA discussed the importance of conducting environmental sampling at least three hours into production to allow for Listeria, if present, to work its way out of hard to clean areas on equipment. Finally, to date, you have not provided a written environmental monitoring plan, as required by 21 CFR 112.145.
2. You did not establish and implement a written sampling plan to test spent sprout irrigation water (SSIW) or in-process sprouts for pathogens that identifies the number and location of samples (SSIW or sprouts) to be collected for each production batch of sprouts to ensure that the collected samples are representative of the production batch when testing for contamination as specified in 21 CFR 112.147, in accordance with 21 CFR 112.144(b). This deviation from the PSR was also observed during a previous inspection of your firm conducted from September 16-18, 2019.
A production batch of sprouts is defined as “all sprouts that are started at the same time in a single growing unit (e.g., a single drum or bin, or a single rack of trays that are connected to each other), whether or not the sprouts are grown from a single lot of seed (including, for example, when multiple types of seeds are grown in a single growing unit).” (21 CFR 112.3). You plant your sprouts from
(b)(4)
. Each of these plantings would be, at a minimum, one production batch of sprouts. However, you stated that you do not collect SSIW for each batch of sprouts, rather, only
(b)(4)
, you take
(b)(4)
that collects SSIW from multiple batches. This is insufficient to ensure that representative samples of SSIW are collected for each production batch of sprouts. We also note that you did not provide any evidence that you held all batches of sprouts pending negative pathogen test results before releasing the sprouts into commerce, as required by 21 CFR 112.147(b).
You stated in your written corrective action plan dated October 20, 2023, that you have adapted your plan to collect SSIW from
(b)(4)
that is
(b)(4)
, and that you will work on putting this in writing. However, under this plan, you would still only take
(b)(4)
for multiple production batches of sprouts.
3. You did not 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). This deviation from the PSR was also observed during a previous inspection of your firm conducted from September 16-18, 2019.
“Food contact surfaces” are defined as those surfaces that contact human food and those surfaces from which drainage, or other transfer, onto the food or onto surfaces that contact the food ordinarily occurs during the normal course of operations (21 CFR 112.3). ‘‘Food contact surfaces’’ includes food contact surfaces of equipment and tools used during harvest, packing, and holding (21 CFR 112.3).
During the inspection, our investigators observed the following conditions:
After you completed your cleaning protocol for the sprouts pool, we nonetheless observed on September 18, 2023, that:
o The sprouts pool was observed with buildup of residue on the walls, bottom of pool and drain covers.
o The belts of the sprouts pool had pieces of sprouts still present on the belts.
o The wall around the sprouts collection table at the end of the sprouts pool had apparent mold growth where sprouts are in contact with the wall.
Separately, throughout the inspection (September 18 – September 22, 2023):
o The mung bean sprout’s growing bins and soybean sprout’s growing buckets were observed to have buildup of brown residues when being actively used for growing your sprouts.
o The metal on the outside of your growing bins and wall holding pins were observed to have buildup of brown residues. This metal was observed to be in direct contact with growing mung bean sprouts.
Additionally, on September 20, 2023, during processing of mung bean sprouts, we observed apparent mold growth at the bottom of your
(b)(4)
dryer. Your drying buckets have holes drilled into them where they sit in the
(b)(4)
drier. You were observed to place these drying buckets on the tabletop after drying where you also dump the mung bean sprouts on the table for packaging.
On September 22, 2023, your mung bean treatment buckets were observed to have a large amount of buildup of orange and brown residue inside of them. The inner surface of these buckets was observed to be rough and hard to clean.
Note that 21 CFR 112.140(b)(1) requires you to document the date and method of equipment cleaning and sanitization used in the growing operation of sprouts.
Videos provided as part of your response and recorded on October 18, 2023, demonstrated how you cleaned the food contact surfaces of the sprout pool with
(b)(4)
and a brush with metal bristles followed by the application of undiluted
(b)(4)
. Your written corrective action plan dated October 20, 2023, stated that you thoroughly cleaned the sprout pool using
(b)(4)
and
(b)(4)
sanitizer. In an e-mail dated October 24, 2023, you described that you added a
(b)(4)
cleaning frequency for the sprout pool in which it will be treated with
(b)(4)
following
(b)(4)
and then a
(b)(4)
which requires the use of
(b)(4)
and then
(b)(4)
.
We find your
(b)(4)
procedure for the sprout pool inadequate. Sanitation must be performed on cleaned surfaces. However, according to your
(b)(4)
procedure, you are not cleaning prior to using
(b)(4)
. We remind you that if you use
(b)(4)
on food contact surfaces you must meet the requirements of 21 CFR Part 178.1010 to use the chemicals at concentrations of
(b)(4)
and to use sanitizing agents that bear labeling that meets the requirements of the Federal Insecticide, Fungicide, and Rodenticide Act.
In your written corrective action plan dated October 20, 2023, you also explained you will add more cleaning steps for the equipment in the grow room as well as develop a written cleaning procedure and record keeping. We cannot evaluate the adequacy of your corrective actions because you did not describe what additional steps will be taken to clean and sanitize the food contact surfaces of equipment and utensils used in growing operations and when they will be taken. In addition, you did not address the cleaning and sanitizing of utensils (buckets and metal scoop) used in drying and packaging operations and bean treatment. Also, you did not provide a timeframe for developing your written cleaning procedures and record keeping. While you provided photographs which appear to show that the apparent mold was removed from the bottom of the
(b)(4)
dryer, you did not provide evidence to show the correction was made to the other equipment and utensils used in growing, drying, and packaging operations.
4. You failed to inspect all of your agricultural water systems at least once annually, to the extent they are under your control (including water sources, water distribution systems, facilities, and equipment), to identify conditions that are reasonably likely to introduce known or reasonably foreseeable hazards into or onto covered produce or food contact surfaces in light of your covered produce, practices, and conditions, as required by 21 CFR 112.42(a). Specifically, your employee stated that you do not conduct annual inspections of your agricultural water system.
On September 22, 2023, we observed that the water storage tank used for your sprout operation was not fully enclosed and would not prevent contamination. On September 21, 2023, we observed that the water inlet pipe in sprout pool
(b)(4)
was fully submerged with no backflow device. This pipe was directly against the inside wall of the sprout pool and could not be moved for cleaning. Additionally, on September 18, 2023, we observed buildup inside the pipe after it was cleaned.
In your written corrective action plan dated October 20, 2023, you promised to develop a written procedure. Further, you stated you sealed the top of the water storage tank and raised the water inlet pipe [in the sprout pool]. However, you did not provide any evidence that you had inspected your agricultural water system or implemented your proposed corrective actions.
5. You did not ensure that agricultural water met the standard of no detectable
Escherichia coli (E. coli)
when used for sprout irrigation, for direct contact with your sprouts during or after harvest activities, and on food contact surfaces, as required by 21 CFR 112.44(a). This deviation from the PSR was also observed during a previous inspection of your firm conducted from September 16-18, 2019.
Specifically, your employee stated that you use
(b)(4)
to irrigate your sprouts, rinse your sprouts, and clean your equipment. You stated that you do not treat or test this
(b)(4)
. In your written corrective action plan dated October 20, 2023, you promised to analyze your
(b)(4)
for
E. coli
as well as develop a written procedure. However, you have not provided any evidence, such as testing records, in support of your proposed corrective actions.
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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing 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 fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Please send your firm’s response to U.S. Food and Drug Administration, Attention: Andrew A. Hoopes, Compliance Officer, 8050 Marshall Drive, Suite 205, Lenexa, KS 66214. If you have questions regarding this letter, please contact Compliance Officer Hoopes at (515) 244-0480 ext. 1002 or via e- mail at: andrew.hoopes@fda.hhs.gov.
Sincerely,
/S/
LaTonya M. Mitchell, Ph.D.
Program Division Director
Office of Human and Animal Food Operations – West Division 2
Cc:
(b)(6), (b)(7)(C)
, Employee
St. Louis Calco, LLC
1336 W. Lark Industrial Dr.
Fenton, MO 63026-4323
(b)(5)
Content current as of:
09/17/2024
Regulated Product(s)
Food & Beverages