FDA Inspection 1253927 — Hanmi Science Co., Ltd.
The FDA completed an inspection of Hanmi Science Co., Ltd. on Nov 8, 2024 in Pyeongtaek. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Nov 8, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Pyeongtaek (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 22702 | 21 CFR 117.135(a)(1) | Process preventive controls - Identify (Written) |
| 2826 | 21 CFR 113.40(g)(1)(ii)(A) | Startup - commercial sterility |
| 2845 | 21 CFR 113.40(g)(1)(i)(B) | Recorder sensor - product holding tube |
| 3834 | 21 CFR 113.40(g)(1)(i)(I) | Operator monitor seals, barriers (S) |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |
| 4524 | 21 CFR 108.35(g) | Approved school |