FDA Inspection 1222431 — Txsyn Int. LLC
The FDA completed an inspection of Txsyn Int. LLC on November 14, 2023 in San Antonio, 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
- November 14, 2023
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Antonio, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15770 | 21 CFR 111.420(a) | Repackaging, relabeling - quality control, approve |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15928 | 21 CFR 111.103 | Written procedure quality control operations material review |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |