FDA Inspection 1061725 — Spartan Enterprises Inc. dba Watershed Wellness Center
The FDA completed an inspection of Spartan Enterprises Inc. dba Watershed Wellness Center on August 10, 2018 in Lansing, MI. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 10, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Lansing, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15499 | 21 CFR 111.27(a) | Equipment - design - suitable |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 16058 | 21 CFR 111.535(b)(2) | Records - ret'nd dietary supplement: material review, dispos |