FDA Inspection 1257006 — Time Challenger Labs International Inc.
The FDA completed an inspection of Time Challenger Labs International Inc. on December 19, 2024 in Round Rock, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- December 19, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Round Rock, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22860 | 21 CFR 111.103 | Written procedures - follow; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |