FDA Inspection 945531 — Starlight LLC
The FDA completed an inspection of Starlight LLC on October 5, 2015 in Burlington, VT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 5, 2015
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Burlington, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15392 | 21 CFR 111.10(b)(4) | Jewelry and objects - remove |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15967 | 21 CFR 111.117(b) | Quality control operations - calibration records |