FDA Inspection 1147795 — Eagles Song Health and Wellness LLC
The FDA completed an inspection of Eagles Song Health and Wellness LLC on July 29, 2021 in Coupeville, WA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 29, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Coupeville, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15571 | 21 CFR 111.153 | Written procedures - packaging |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15865 | 21 CFR 111.75(a)(2)(ii)(D) | Re-confirm certificate of analysis |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15920 | 21 CFR 111.95(b)(1) | Records - established specifications |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16046 | 21 CFR 111.503 | Written procedures returned dietary supplement investigation |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |