FDA Inspection 1174276 — Pinnacle Labs International, Inc.
The FDA completed an inspection of Pinnacle Labs International, Inc. on Jul 5, 2022 in Upland, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 5, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Upland, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15498 | 21 CFR 111.27(d) | Equipment - maintain, clean, sanitize |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |