FDA Inspection 680062 — MIDANG Co. Ltd.
The FDA completed an inspection of MIDANG Co. Ltd. on August 17, 2010 in Suwon. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 17, 2010
- Fiscal Year
- 2010
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Suwon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1532 | 21 CFR 113.100(a)(7) | Other systems - records; critical factors |
| 1642 | 21 CFR 113.100(b) | Review not signed/dated |
| 2886 | 21 CFR 113.40(i) | Thermal process crit factors-measurement adequate & accurate |
| 2887 | 21 CFR 113.40(j) | Processing: conform to other systems |
| 2888 | 21 CFR 113.40(j) | Critical factors - frequency measured, recorded |
| 3068 | 21 CFR 114.80(a)(1) | pH control |
| 3857 | 21 CFR 113.60(a) | Record: visual closure examination, qualified person |
| 3872 | 21 CFR 113.60(a)(3) | Closures other than double seams and glass |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4524 | 21 CFR 108.35(g) | Approved school |