FDA Inspection 1275069 — REAL CONSERVERA ESPANOLA, S.L.
The FDA completed an inspection of REAL CONSERVERA ESPANOLA, S.L. on June 10, 2025 in Pontevedra. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 10, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Pontevedra (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 1331 | 21 CFR 113.100(a)(1) | Still retorts |
| 1501 | 21 CFR 113.89 | Evaluation records |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |