FDA Inspection 1275947 — DAWTONA Sp.zo.o
The FDA completed an inspection of DAWTONA Sp.zo.o on June 27, 2025 in Leszno. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 27, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Leszno (Poland)
Citations
| ID | CFR | Description |
|---|---|---|
| 1484 | 21 CFR 113.87(a) | Vent not posted |
| 16354 | 21 CFR 113.40(c)(5) | Continuous agitating retorts: bleeders wide open |
| 16368 | 21 CFR 113.40(c)(1)(iv) | Continuous agitating retorts: TID not accurate to 1°F |
| 2334 | 21 CFR 113.40(c)(5) | Operator observe function |
| 2342 | 21 CFR 113.40(c)(6) | Heat distribution data not on file |
| 2581 | 21 CFR 113.40(c)(10) | Measured and recorded |
| 3867 | 21 CFR 113.60(a)(1)(i)(b) | Required can seam measurements (seam scope) |
| 3874 | 21 CFR 113.60(b) | Cooling water - not chlorinated, sanitized |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |