793643
Glucorell, Inc. — FEI 3004699389
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 7, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |