Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1the FDA investigator observed a packaging employee using a frayed, ripped towel to wipe the surface of a scratched wooden packaging table and then wiping their gloved hands on the same towel. Without removing or changing their gloves, the employee immediately proceeded to hand-package RTE products.
Passage 2the FDA investigator did not observe any employees apply sanitizer after donning their gloves and before touching RTE products.
Passage 3the FDA investigator observed spilled nuts on the floor of the freezer, beside cases holding macadamia nuts and almonds. During the inspection, your firm began to clean the spilled nuts, but the FDA investigator noted there were still some nuts on the floor as of November 7, 2025.
Passage 4the FDA investigator observed overgrown weeds, other vegetation, and unused equipment stored directly outside the building (near the employee entrance and outdoor break area). Overgrown vegetation and equipment that is not properly stored could constitute an attractant, breeding place, or harborage for pests.
Passage 5the FDA investigator observed at least three apparent gnats on a cookie decorating table and one apparent rodent excreta pellet on the lower shelf of the dry storage rack. The FDA investigator also observed an approximate (b)(4) gap in the top of the warehouse dock door, creating a potential pest entry point.
Passage 6the FDA investigator observed that the raw dough conveyor belt had two areas of fraying edges, measuring approximately (b)(4) long. Fraying edges of conveyor belts could become harborage points for contaminants and could shed into products such as the Linzer Heart cookies.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 117
- 21 CFR 117.135(a)(1)
- 21 CFR 117.20(a)
- 21 CFR 117.35(c)
- 21 CFR 117.40(a)(1)
- 21 CFR 117.35(a)