FDA Inspection 769384 — Universal Holdings I LLC
The FDA completed an inspection of Universal Holdings I LLC on Mar 2, 2012 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 18 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 2, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Chicago, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1223 | 21 CFR 211.67(b)(5) | Cleaning SOPs/equipment protection |
| 1306 | 21 CFR 110.20(b)(7) | Screening |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 1630 | 21 CFR 211.130(b) | Unlabeled filled containers controls |
| 1709 | 21 CFR 110.80(b)(13) | Filling, assembling, packing controls |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 3608 | 21 CFR 211.160(b)(2) | Sampling/testing of in-process materials |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |