FDA Inspection 858808 — AMK Food Export (Pvt) Ltd
The FDA completed an inspection of AMK Food Export (Pvt) Ltd on December 10, 2013 in Homagama. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 10, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Homagama (Sri Lanka)
Citations
| ID | CFR | Description |
|---|---|---|
| 1331 | 21 CFR 113.100(a)(1) | Still retorts |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1651 | 21 CFR 113.40(a)(1) | TID accuracy test frequency |
| 3075 | 21 CFR 114.80(a)(4) | Container testing |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4524 | 21 CFR 108.35(g) | Approved school |
| 961 | 21 CFR 123.6(c)(3) | Critical limits |