FDA Inspection 932319 — AMK Food Export (Pvt) Ltd
The FDA completed an inspection of AMK Food Export (Pvt) Ltd on June 24, 2015 in Homagama. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 24, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Homagama (Sri Lanka)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1581 | 21 CFR 110.37(e) | Running water at suitable temperature |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 1711 | 21 CFR 110.80(b)(15) | Proper pH controls |
| 3062 | 21 CFR 114.10 | Personnel |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3073 | 21 CFR 114.80(a)(2) | pH testing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |
| 3088 | 21 CFR 114.100(b) | Processing and production - required information |
| 3652 | 21 CFR 110.37(e)(1) | Suitable locations |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |
| 904 | 21 CFR 123.6(b) | No HACCP plan |