FDA Inspection 877815 — Sixdog Investments, LLC
The FDA completed an inspection of Sixdog Investments, LLC on May 29, 2014 in Wellington, CO. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 43 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 29, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Wellington, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1125 | 21 CFR 110.40(a) | Materials and workmanship |
| 1292 | 21 CFR 110.20(b)(1) | Sufficient space |
| 1422 | 21 CFR 110.20(b)(4) | Floors, walls and ceilings |
| 1424 | 21 CFR 110.20(b)(4) | Drip and condensate |
| 1427 | 21 CFR 110.20(b)(5) | Safety lighting and glass |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1562 | 21 CFR 110.35(d) | Failure to clean - general |
| 1597 | 21 CFR 110.37(b)(3) | As source of contamination |
| 1598 | 21 CFR 110.37(b)(4) | Drainage |
| 16118 | 21 CFR 118.4 | Written SE plan not implemented/followed |
| 16119 | 21 CFR 118.4(a)(1) | Procurement of chicks |
| 16120 | 21 CFR 118.4 | Written SE plan lacks required elements |
| 16122 | 21 CFR 118.4(a)(2)(i) | Pullet environment testing |
| 16131 | 21 CFR 118.4(b) | Transfer or introduction of SE |
| 16132 | 21 CFR 118.4(b)(1) | Limiting visitors |
| 16133 | 21 CFR 118.4(b)(2) | Cross contamination from equipment |
| 16134 | 21 CFR 118.4(b)(3) | Cross contamination from people |
| 16135 | 21 CFR 118.4(b)(4) | Stray animals |
| 16136 | 21 CFR 118.4(b)(5) | Employees keeping birds at home |
| 16144 | 21 CFR 118.4(d) | Before new laying hens added |
| 16149 | 21 CFR 118.4(e) | Egg transport temperature/time |
| 1615 | 21 CFR 110.93 | Storage/transportation of finished goods (contamination) |
| 16152 | 21 CFR 118.5(a) | Testing when laying hens 40 to 45 weeks |
| 16162 | 21 CFR 118.6(a)(2) | SE positive test any time during life of flock |
| 16183 | 21 CFR 118.9 | Supervisor(s) training/job experience |
| 16191 | 21 CFR 118.10(a)(2) | Pullets records documentation |
| 16192 | 21 CFR 118.10(a)(3)(i) | Biosecurity measures documentation |
| 16193 | 21 CFR 118.10(a)(3)(ii) | Rodent and pest control documentation |
| 16194 | 21 CFR 118.10(a)(3)(iii) | Depopulation cleaning and disinfection procedures |
| 16195 | 21 CFR 118.10(a)(3)(iv) | Refrigeration requirements documentation |
| 16198 | 21 CFR 118.10(a)(3)(vii) | Egg diversion documentation |
| 16203 | 21 CFR 118.10(b)(1) | Name and location |
| 16206 | 21 CFR 118.10(b)(3) | Signature and date on SE plans |
| 16510 | FDCA 402(a)(4) | On farm processing of shell eggs |
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 1695 | 21 CFR 110.80(b)(2) | Manufacturing conditions |
| 1698 | 21 CFR 110.80(b)(5) | Work-in-progress |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |
| 3659 | 21 CFR 110.37(e)(3) | Hand drying |
| 4295 | 21 CFR 110.40(a) | Food contact - non-toxic materials |
| 990 | 21 CFR 110.10(b)(3) | Not washed/sanitized when appropriate |