Dough-To-Go, Inc.
6 extracted findings · 2 model-assigned issue types
FDA source excerpt, selected passage
the 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.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
A packaging employee used a frayed, ripped towel to wipe a scratched wooden table and then their gloved hands before hand-packaging RTE products, contrary to the GMP policy.
Supporting FDA text
Source excerpt · automated text-match checkthe 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.
Employees did not apply sanitizer after donning gloves and before touching RTE products, as required by the GMP policy.
Supporting FDA text
Source excerpt · automated text-match checkthe FDA investigator did not observe any employees apply sanitizer after donning their gloves and before touching RTE products.
Spilled nuts remained on the freezer floor beside cases of macadamia nuts and almonds, indicating failure to control allergen cross-contact.
Supporting FDA text
Source excerpt · automated text-match checkthe 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.
Overgrown weeds, vegetation, and unused equipment outside the building could attract pests, and a trap showed heavy mice activity.
Supporting FDA text
Source excerpt · automated text-match checkthe 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.
Gnats, a rodent excreta pellet, and a gap in the warehouse dock door were observed, indicating failure to exclude pests.
Supporting FDA text
Source excerpt · automated text-match checkthe 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.
The raw dough conveyor belt had fraying edges, a repeat observation from prior inspections, and could shed into products.
Supporting FDA text
Source excerpt · automated text-match checkthe 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.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
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What FDA requested
Model-assisted summary. Consult the letter for complete requests and conditions.
- Notify FDA in writing within 15 working days of specific steps taken to address violations.
- Include an explanation of each step to prevent recurrence and copies of related documentation.
- State reason for delay and time frame if corrective actions cannot be completed within 15 working days.
- Include reasoning and supporting information if products are believed not in violation.
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.