FDA Inspection 1007313 — TBN Labs, LLC.
The FDA completed an inspection of TBN Labs, LLC. on March 31, 2017 in Hauppauge, NY. 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
- March 31, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |