829555
Blue Light, Inc. — FEI 3000210807
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 11, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Ithaca, NY (United States)
Citations
| ID | CFR | Description |
|---|
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |