FDA Inspection 782542 — Starlight LLC
The FDA completed an inspection of Starlight LLC on May 15, 2012 in Burlington, VT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Burlington, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15410 | 21 CFR 111.14(b)(2) | Personnel - records - training |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15507 | 21 CFR 111.27(a)(5)(i) | Refrigerator, freezer - temperature recording device |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |