FDA Inspection 1006802 — Dae Young Foods Co., Ltd.
The FDA completed an inspection of Dae Young Foods Co., Ltd. on March 17, 2017 in Boeun. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 17, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boeun (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 16218 | 21 CFR 118.11(b)(2)(vi) | Updating previously submitted info |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3582 | 21 CFR 211.105(a) | Identification of containers, lines, equipment |
| 4317 | 21 CFR 211.84(d)(3) | Certificates of Testing (Containers, Closures) |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |