FDA Inspection 599605 — TM Seafood LLC
The FDA completed an inspection of TM Seafood LLC on July 10, 2009 in Elmira, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 10, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Elmira, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1292 | 21 CFR 110.20(b)(1) | Sufficient space |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1524 | 21 CFR 123.11(b) | Sanitation monitoring |
| 1701 | 21 CFR 110.80(b)(7) | Equipment, containers, utensils |
| 6004 | 21 CFR 123.6(c)(4) | Monitoring - adequacy |
| 6007 | 21 CFR 123.9(a) | Records entries - timing |
| 6010 | 21 CFR 123.8(a)(3)(i) | Monitoring record review adequacy |
| 6019 | 21 CFR 123.8(a)(2) | Ongoing verification - complaints, calibration records |
| 6020 | 21 CFR 123.9(a) | Records - content |
| 904 | 21 CFR 123.6(b) | No HACCP plan |
| 905 | 21 CFR 123.6(b) | HACCP plan implementation |
| 908 | 21 CFR 123.6(d) | Signed and dated |
| 913 | 21 CFR 123.8(a)(1) | Reassessment of HACCP plan |