FDA Inspection 1050722 — IP-6 International, Inc.
The FDA completed an inspection of IP-6 International, Inc. on May 2, 2018 in Melbourne, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Melbourne, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15400 | 21 CFR 111.12(a) | Personnel - qualified - general |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15801 | 21 CFR 111.560(b) | Quality control, review, approve; investigate, follow-up |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |