FDA Inspection 685014 — Sung Won Inc. of Columbia
The FDA completed an inspection of Sung Won Inc. of Columbia on October 12, 2010 in Columbia, MD. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 12, 2010
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Columbia, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1426 | 21 CFR 110.20(b)(5) | Adequate lighting |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1698 | 21 CFR 110.80(b)(5) | Work-in-progress |
| 2389 | 21 CFR 110.80(a)(5) | Identify rework |
| 3645 | 21 CFR 110.10(d) | Supervision |
| 6005 | 21 CFR 123.6(c)(6) | Verification procedures - adequacy |
| 6018 | 21 CFR 123.7(a) | Corrective action per predetermined plan |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 904 | 21 CFR 123.6(b) | No HACCP plan |
| 959 | 21 CFR 123.6(c)(1) | Food safety hazards |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |