FDA Inspection 1197143 — Grupo De Hongo Zeta Endotzi SPR De RL
The FDA completed an inspection of Grupo De Hongo Zeta Endotzi SPR De RL on Feb 2, 2023 in Jiquipilco. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 2, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Jiquipilco (Mexico)
Citations
| ID | CFR | Description |
|---|---|---|
| 1040 | 21 CFR 113.10 | Operators |
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1319 | 21 CFR 113.87(f) | Thermal processing - steam supply |
| 1331 | 21 CFR 113.100(a)(1) | Still retorts |
| 1472 | 21 CFR 113.83 | Critical factors not stated |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2111 | 21 CFR 113.40(b)(4) | Steam controller |
| 2150 | 21 CFR 113.40(b)(2) | Present each retort, accurate |
| 2167 | 21 CFR 113.40(b)(10) | No indicator |
| 3873 | 21 CFR 113.60(a)(3) | Closure exams other than double seams or glass - records |
| 4517 | 21 CFR 108.35(c)(2)(ii) | Process change substantiation |
| 4518 | 21 CFR 108.35(c)(2)(ii) | Process change - increase |