FDA Inspection 846015 — BAUDERER PACKAGING, LLC
The FDA completed an inspection of BAUDERER PACKAGING, LLC on August 22, 2013 in Addison, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 22, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Addison, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15768 | 21 CFR 111.420(c) | Repackaged, relabeled - quality control: approve, rejects |
| 15769 | 21 CFR 111.420(b) | Repackaged, relabeled - specifications |
| 15770 | 21 CFR 111.420(a) | Repackaging, relabeling - quality control, approve |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15783 | 21 CFR 111.410(d) | Manufacturing history |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |