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
- 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
