FDA Inspection 1122207 — BJP Laboratories Pty Ltd
The FDA completed an inspection of BJP Laboratories Pty Ltd on Mar 4, 2020 in Yatala. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 4, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Yatala (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1471 | 21 CFR 113.83 | Scheduled processes not established |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15986 | 21 CFR 111.123(b)(2) | Quality control - batch, product specifications |
| 4514 | 21 CFR 108.35(c)(1) | Registration |