Issues noted in the Warning Letter:
WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pl-bean-sprout-farm-680777-07312024
Recipient:
Haoyang Pei
Owner
P&L Bean Sprout Farm
266 Forest Manor Rd
Cochranville, PA 19330
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
WARNING LETTER
CMS #680777
July 31, 2024
Dear Ms. Pei,
The U.S. Food and Drug Administration (FDA) inspected your sprouting operation, located at 266 Forest Manor Road, Cochranville, Pennsylvania, from January 31, 2024, through March 12, 2024. Our inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act).
Based on conditions and practices documented during our inspection, we have determined that your mung bean and soybean sprout products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 324(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.
The inspection resulted in the issuance of a Form FDA 483, Inspectional Observations, listing the violations found at your sprouting operation. During the inspection closeout meeting, you proposed corrective actions. We address your proposed corrective actions below.
Violations of the Act
During the inspection, FDA investigators observed the following insanitary conditions:
1. On January 31, 2024, FDA investigators observed gray sludge falling from the railing where the automatic sprinkler system is mounted and accumulating in sprouts growing below. You told our investigator that this gray sludge was food-grade oil. However, you were unable to provide FDA investigators the container or labeling of the apparent oil. Further, the substance appeared dirty.
During the inspection closeout meeting, you stated that you would discard sprouts that may have become contaminated. However, we note that you stated that on February 2, 2024, you had introduced into commerce the sprouts observed on January 31, 2024. In addition, you did not address how to prevent the contamination of in-process sprouts in the future.
2. FDA observed apparent rodent excreta pellets underneath a table in the packaging room, where packaging material used for ready to eat (RTE) mung bean sprouts was being stored.
This finding demonstrates that rodents have access to food contact surfaces and may have directly or indirectly contaminated the sprouts with feces. Your third-party pest control company documented rodent activity on November 28, 2023, December 26, 2023, and January 23, 2024, and recommended actions to prevent recurrence. You did not implement any of these recommended actions.
During the inspection closeout meeting, you stated that you will work with your pest control company. However, as of the date of this letter, we have not received any documentation of any corrective action.
3. FDA also observed conditions that may result in your sprouts contacting contaminated surfaces. For example:
a. The ceiling in the sprout processing area has peeling and chipped paint, and apparent cobwebs and insect frass directly above the open sprout harvesting machine. This may have resulted in the contamination of your sprouts with paint and insect frass.
b. The floor directly under the sprout harvesting machine in the sprout processing area was wet, pitted, and cracked. This may cause the floor to be a harborage site for pathogens. On January 31, 2024, and February 1, 2024, FDA investigators observed a pressurized hose used to rinse food contact surface equipment and in-process sprouts frayed and stored on the floor in the sprout production room. This may have resulted in the contamination of your sprouts with any substances, including any pathogens, from the floor.
c. Furthermore, the hose described above was used without being cleaned or sanitized. An employee with gloved hands touched the circuit breaker, cleaned a seed bed, handled the hose, and then returned to handling sprouts without either changing their gloves or removing the gloves and handling the sprouts with clean hands. This may have resulted in the gloves contaminating the sprouts with any substances contacting the gloves prior to hose handling.
During the inspection closeout meeting, you stated that replacing the observed area of the floor would be expensive, and that it would be the responsibility of the new owner to fix if you can sell the property. You also stated that you or a new owner would fix the ceiling. Additionally, you stated that you will install a holding device for your hose. However, as of the date of this letter, we have not received any documentation of any corrective action. Further, you provided no evidence of a sale to a new owner and indicated during the closeout meeting that you will continue to grow, harvest, and package RTE sprouts. It is your responsibility to ensure that your sprouts are not adulterated.
Pest control, building maintenance, and employee handling practices were repeat observations from the previous inspection of your sprouting operation, conducted March 7, 2023, through March 31, 2023. These observations were discussed during a post-inspection regulatory meeting conducted by FDA on May 24, 2023.
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.
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 FDA without further notice, including, without limitation, seizure and/or injunction.
Modified Requirements for Qualified Facilities
Your sprout operation is eligible for a qualified exemption1 under the 21 Code of Federal Regulation, Part 112 (21 CFR 112), Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Rule), and therefore is subject to the modified requirements of the Produce Safety Rule in 21 CFR 112.6 and 21 CFR 112.7.
Pursuant to Subpart R of the Produce Safety Rule, FDA may withdraw your qualified exemption in the following circumstances: 1) in the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm, or 2) if FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with your farm that are material to the safety of the food that would otherwise be covered produce grown, harvested, packed, or held at your farm. If the qualified exemption is withdrawn, you will no longer be subject to the modified requirements within 21 CFR 112.6 and 21 CFR 112.7, and instead would be subject to all relevant requirements in the Produce Safety Rule. You can find the Produce Safety Rule and the Act through links on FDA’s homepage at FDA.gov.
We also offer the following comment:
During the inspection, we observed that an exit door is in poor repair and unable to fully close to exclude pests from entering the facility. Additionally, there were harborage conditions around the perimeter of the facility that potentially attract pests, including sprouts around the external cement block of the unplugged trash receptacle and empty plastic containers behind the building. During the inspection closeout meeting, you stated that you would remove vegetation around the building and discard waste materials at the perimeter of the property. You also stated that fixing the door may take some time because of the financial strain. We acknowledge this. However, it is your responsibility to ensure that your sprouts are not adulterated.
Please notify FDA in writing within fifteen (15) working days of the 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 action within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented. 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.
Sincerely,
/S/
Randy F. Pack
Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
Randy.Pack@fda.hhs.gov
- FDA investigators observed gray sludge falling from the railing where the automatic sprinkler system is mounted and accumulating in sprouts growing below. The company told our investigator that this gray sludge was food-grade oil. However, the company was not able to provide FDA investigators the container or labeling of the apparent oil. Further, the substance appeared dirty. Further, during the inspection closeout meeting, the company stated that the sprouts that may have become contaminated would be discarded, however, the company had introduced into commerce the sprouts observed on that date. In addition, the company did not address how to prevent the contamination of in-process sprouts in the future.
- FDA observed apparent rodent excreta pellets underneath a table in the packaging room, where packaging material used for ready to eat (RTE) mung bean sprouts was being stored. This finding demonstrates that rodents have access to food contact surfaces and may have directly or indirectly contaminated the sprouts with feces. The third-party pest control company documented rodent activity on November 28, 2023, December 26, 2023, and January 23, 2024, and recommended actions to prevent recurrence, however, the company did not implement any of these recommended actions.
- Facility issues included a) The ceiling in the sprout processing area has peeling and chipped paint, and apparent cobwebs and insect frass directly above the open sprout harvesting machine. b) The floor directly under the sprout harvesting machine in the sprout processing area was wet, pitted, and cracked. This may cause the floor to be a harborage site for pathogens.
- On January 31, 2024, and February 1, 2024, FDA investigators observed a pressurized hose used to rinse food contact surface equipment and in-process sprouts frayed and stored on the floor in the sprout production room. This may have resulted in the contamination of your sprouts with any substances, including any pathogens, from the floor. Furthermore, the hose described above was used without being cleaned or sanitized. An employee with gloved hands touched the circuit breaker, cleaned a seed bed, handled the hose, and then returned to handling sprouts without either changing their gloves or removing the gloves and handling the sprouts with clean hands. This may have resulted in the gloves contaminating the sprouts with any substances contacting the gloves prior to hose handling.
- During the inspection, we observed that an exit door is in poor repair and unable to fully close to exclude pests from entering the facility. Additionally, there were harborage conditions around the perimeter of the facility that potentially attract pests, including sprouts around the external cement block of the unplugged trash receptacle and empty plastic containers behind the building.
WARNING LETTER
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/pl-bean-sprout-farm-680777-07312024
P&L Bean Sprout Farm
MARCS-CMS 680777 — July 31, 2024
MARCS-CMS 680777 — July 31, 2024
Recipient:
Haoyang Pei
Owner
P&L Bean Sprout Farm
266 Forest Manor Rd
Cochranville, PA 19330
United States
Issuing Office:
Division of Human and Animal Food Operations East II
United States
WARNING LETTER
CMS #680777
July 31, 2024
Dear Ms. Pei,
The U.S. Food and Drug Administration (FDA) inspected your sprouting operation, located at 266 Forest Manor Road, Cochranville, Pennsylvania, from January 31, 2024, through March 12, 2024. Our inspection revealed serious violations of the Federal Food, Drug, and Cosmetic Act (the Act).
Based on conditions and practices documented during our inspection, we have determined that your mung bean and soybean sprout products are adulterated within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 324(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.
The inspection resulted in the issuance of a Form FDA 483, Inspectional Observations, listing the violations found at your sprouting operation. During the inspection closeout meeting, you proposed corrective actions. We address your proposed corrective actions below.
Violations of the Act
During the inspection, FDA investigators observed the following insanitary conditions:
1. On January 31, 2024, FDA investigators observed gray sludge falling from the railing where the automatic sprinkler system is mounted and accumulating in sprouts growing below. You told our investigator that this gray sludge was food-grade oil. However, you were unable to provide FDA investigators the container or labeling of the apparent oil. Further, the substance appeared dirty.
During the inspection closeout meeting, you stated that you would discard sprouts that may have become contaminated. However, we note that you stated that on February 2, 2024, you had introduced into commerce the sprouts observed on January 31, 2024. In addition, you did not address how to prevent the contamination of in-process sprouts in the future.
2. FDA observed apparent rodent excreta pellets underneath a table in the packaging room, where packaging material used for ready to eat (RTE) mung bean sprouts was being stored.
This finding demonstrates that rodents have access to food contact surfaces and may have directly or indirectly contaminated the sprouts with feces. Your third-party pest control company documented rodent activity on November 28, 2023, December 26, 2023, and January 23, 2024, and recommended actions to prevent recurrence. You did not implement any of these recommended actions.
During the inspection closeout meeting, you stated that you will work with your pest control company. However, as of the date of this letter, we have not received any documentation of any corrective action.
3. FDA also observed conditions that may result in your sprouts contacting contaminated surfaces. For example:
a. The ceiling in the sprout processing area has peeling and chipped paint, and apparent cobwebs and insect frass directly above the open sprout harvesting machine. This may have resulted in the contamination of your sprouts with paint and insect frass.
b. The floor directly under the sprout harvesting machine in the sprout processing area was wet, pitted, and cracked. This may cause the floor to be a harborage site for pathogens. On January 31, 2024, and February 1, 2024, FDA investigators observed a pressurized hose used to rinse food contact surface equipment and in-process sprouts frayed and stored on the floor in the sprout production room. This may have resulted in the contamination of your sprouts with any substances, including any pathogens, from the floor.
c. Furthermore, the hose described above was used without being cleaned or sanitized. An employee with gloved hands touched the circuit breaker, cleaned a seed bed, handled the hose, and then returned to handling sprouts without either changing their gloves or removing the gloves and handling the sprouts with clean hands. This may have resulted in the gloves contaminating the sprouts with any substances contacting the gloves prior to hose handling.
During the inspection closeout meeting, you stated that replacing the observed area of the floor would be expensive, and that it would be the responsibility of the new owner to fix if you can sell the property. You also stated that you or a new owner would fix the ceiling. Additionally, you stated that you will install a holding device for your hose. However, as of the date of this letter, we have not received any documentation of any corrective action. Further, you provided no evidence of a sale to a new owner and indicated during the closeout meeting that you will continue to grow, harvest, and package RTE sprouts. It is your responsibility to ensure that your sprouts are not adulterated.
Pest control, building maintenance, and employee handling practices were repeat observations from the previous inspection of your sprouting operation, conducted March 7, 2023, through March 31, 2023. These observations were discussed during a post-inspection regulatory meeting conducted by FDA on May 24, 2023.
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.
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 FDA without further notice, including, without limitation, seizure and/or injunction.
Modified Requirements for Qualified Facilities
Your sprout operation is eligible for a qualified exemption1 under the 21 Code of Federal Regulation, Part 112 (21 CFR 112), Standard for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (the Produce Safety Rule), and therefore is subject to the modified requirements of the Produce Safety Rule in 21 CFR 112.6 and 21 CFR 112.7.
Pursuant to Subpart R of the Produce Safety Rule, FDA may withdraw your qualified exemption in the following circumstances: 1) in the event of an active investigation of a foodborne illness outbreak that is directly linked to your farm, or 2) if FDA determines that it is necessary to protect the public health and prevent or mitigate a foodborne illness outbreak based on conduct or conditions associated with your farm that are material to the safety of the food that would otherwise be covered produce grown, harvested, packed, or held at your farm. If the qualified exemption is withdrawn, you will no longer be subject to the modified requirements within 21 CFR 112.6 and 21 CFR 112.7, and instead would be subject to all relevant requirements in the Produce Safety Rule. You can find the Produce Safety Rule and the Act through links on FDA’s homepage at FDA.gov.
We also offer the following comment:
During the inspection, we observed that an exit door is in poor repair and unable to fully close to exclude pests from entering the facility. Additionally, there were harborage conditions around the perimeter of the facility that potentially attract pests, including sprouts around the external cement block of the unplugged trash receptacle and empty plastic containers behind the building. During the inspection closeout meeting, you stated that you would remove vegetation around the building and discard waste materials at the perimeter of the property. You also stated that fixing the door may take some time because of the financial strain. We acknowledge this. However, it is your responsibility to ensure that your sprouts are not adulterated.
Please notify FDA in writing within fifteen (15) working days of the 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 action within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be implemented. 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.
Sincerely,
/S/
Randy F. Pack
Program Division Director
Baltimore District Office
Human & Animal Food East, Division 2
Office of Regulatory Affairs
U.S. Food and Drug Administration
Randy.Pack@fda.hhs.gov
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