FDA Inspection 1084535 — Eredi di Donato Mancuso S.p.A.
The FDA completed an inspection of Eredi di Donato Mancuso S.p.A. on March 15, 2019 in Sarno. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 15, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Sarno (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 19039 | 21 CFR 117.150(a)(1) | Process Controls Corrective Action Proced: Estab Implement |
| 19044 | 21 CFR 117.165(b) | Process Controls Verif Procedures: Establish Implement |
| 19045 | 21 CFR 117.160(a) | Process controls - Validation |
| 19047 | 21 CFR 117.155(b) | Process Controls Verification Records |