FDA Inspection 1087383 — Global Vitality Inc.
The FDA completed an inspection of Global Vitality Inc. on April 24, 2019 in Chandler, AZ. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 24, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Chandler, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15535 | 21 CFR 111.255(d) | Batch record - 1 year, 2 years |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15704 | 21 CFR 111.325(a) | Laboratory operations: 1 year, 2 years |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15833 | 21 CFR 111.70(c)(1) | Specifications - in-process contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |