FDA Inspection 1238999 — FCC Horiuchi Co., Ltd.
The FDA completed an inspection of FCC Horiuchi Co., Ltd. on May 17, 2024 in Kurume. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 17, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Kurume (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 4475 | 21 CFR 108.25(c)(3)(i) | Process adherence |
| 4511 | 21 CFR 108.25(f) | Approved school |