FDA Inspection 579101 — Nutripack LLC
The FDA completed an inspection of Nutripack LLC on Apr 15, 2009 in Markham, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 33 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 15, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Markham, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1245 | 21 CFR 113.81(a) | Raw ingredients |
| 1287 | 21 CFR 110.20(a)(1) | Harborage areas |
| 1289 | 21 CFR 110.20(a)(3) | Drainage |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1317 | 21 CFR 113.87(d) | Thermal processing - timing devices |
| 1324 | 21 CFR 113.100(f) | Distribution record |
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 1473 | 21 CFR 113.83 | Scheduled process - scientific methods not used |
| 1499 | 21 CFR 113.89 | No corrective action taken |
| 1500 | 21 CFR 113.89 | Evaluation by process authority |
| 1529 | 21 CFR 113.89 | Process deviation log/file |
| 1533 | 21 CFR 113.100(b) | Recording device records - dated; retort number |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1561 | 21 CFR 110.35(c) | Insecticides/rodenticides |
| 1639 | 21 CFR 113.100(b) | Entry not timely |
| 1640 | 21 CFR 113.100(b) | Record form not signed |
| 1641 | 21 CFR 113.100(b) | Review not timely |
| 1643 | 21 CFR 113.100(e) | Incomplete information |
| 1644 | 21 CFR 113.100(e) | Not signed by closure inspector |
| 1645 | 21 CFR 113.100(e) | Insufficient frequency of management review |
| 1658 | 21 CFR 113.40(a)(1)(v) | TID bleeder location - steam flow |
| 1691 | 21 CFR 113.40(a)(4) | Steam controller |
| 1731 | 21 CFR 113.40(a)(2) | Present each retort, accurate |
| 1734 | 21 CFR 113.40(a)(2)(iii) | Adjusted to agree with TID |
| 1853 | 21 CFR 113.40(a)(9) | Suitable material |
| 1865 | 21 CFR 113.40(a)(12) | Timing before vent, before temperature reached |
| 3864 | 21 CFR 113.60(a)(1) | Recording of teardown examinations |
| 3876 | 21 CFR 113.60(c) | Coding - no mark, permanently visible |
| 3877 | 21 CFR 113.60(c) | Coding - required elements |
| 4179 | 21 CFR 113.83 | Records of process establishment |
| 4515 | 21 CFR 108.35(c)(2) | Process filing |
| 4521 | 21 CFR 108.35(d) | Notify FDA - spoilage |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |