The biggest concern was that FDA found Salmonella on environmental samples which demonstrated a lack of control. "FDA laboratory analysis confirmed 10 of 174 environmental swabs collected were positive for Salmonella Cubana. Of these positive findings, three positive swabs were collected from the (b)(4) room, a room that you consider a primary pathogen control area where products are exposed to the environment and include the following locations: a crack in the wall and floor junction adjacent to (b)(4); the floor and stair junction of the mezzanine level which employees climb to access ribbon blenders; and the floor drain cover adjacent to the mezzanine stairs. Additionally, three positive swabs were collected from the agglomeration room, including the equipment framework under Line (b)(4)."
Further, this Salmonella strain was determined to be a resident organism. Again, FDA - "Whole genome sequencing (WGS) was conducted on the Salmonella isolates obtained from the 2021 FDA environmental samples, and the current WGS analysis determined that the 2021 isolates matched isolates from three other environmental samples including FDA sample 437365, FDA sample 892439, and FDA sample 940886, which were collected from this facility location in 2009, 2016, and 2017, respectively. The presence of the same strain of Salmonella over multiple years indicates there has been a resident pathogen in your facility since at least 2009."
Further, this Salmonella strain was determined to be a resident organism. Again, FDA - "Whole genome sequencing (WGS) was conducted on the Salmonella isolates obtained from the 2021 FDA environmental samples, and the current WGS analysis determined that the 2021 isolates matched isolates from three other environmental samples including FDA sample 437365, FDA sample 892439, and FDA sample 940886, which were collected from this facility location in 2009, 2016, and 2017, respectively. The presence of the same strain of Salmonella over multiple years indicates there has been a resident pathogen in your facility since at least 2009."
The facility was trying to control the environment through prerequisite programs rather than establishing this as a Sanitation Preventive Control. The company's own environmental testing program had found salmonella, but they never did sufficient corrective action to eliminate the organism. In addition, GMP issues seemed to be spreading the organism (fork lifts with positive samples on the wheels).
History has shown that facilities with this level of contamination will be hard pressed to rid itself of this resident Salmonella.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ofp-ingredients-llc-617124-12072021
OFP Ingredients LLC
MARCS-CMS 617124 — DECEMBER 07, 2021
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/ofp-ingredients-llc-617124-12072021
OFP Ingredients LLC
MARCS-CMS 617124 — DECEMBER 07, 2021
