FDA Inspection 1254403 — Tri-Light Health, Inc.
The FDA completed an inspection of Tri-Light Health, Inc. on Nov 15, 2024 in La Vergne, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 16 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 15, 2024
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- La Vergne, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15581 | 21 CFR 111.155(c)(3) | Quality control - components, approve, release |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22827 | 21 CFR 111.16 | Written procedures - establish; cleaning |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22867 | 21 CFR 111.140(b)(1) | Quality control operations; written procedures; material review, disposition |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |