FDA Inspection 1220491 — Spartan Enterprises Inc. dba Watershed Wellness Center
The FDA completed an inspection of Spartan Enterprises Inc. dba Watershed Wellness Center on October 17, 2023 in Lansing, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 17, 2023
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Lansing, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15545 | 21 CFR 111.260(e) | Batch record - component; identity, weight |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15555 | 21 CFR 111.260(j)(2)(iii) | Batch record - initials; component |
| 15556 | 21 CFR 111.260(j)(2)(iv) | Batch record - initials; verifying component |
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15746 | 21 CFR 111.210(h)(1) | Instructions; specifications; quality |
| 15747 | 21 CFR 111.210(g) | Packaging description, representative label |
| 15754 | 21 CFR 111.210(a) | Master manufacturing record - dietary ingredients |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15864 | 21 CFR 111.75(a)(2)(ii)(C) | Documentation - qualify supplier |