FDA Inspection 1061725 — Spartan Enterprises Inc.
The FDA completed an inspection of Spartan Enterprises Inc. on Aug 10, 2018 in Lansing, MI. 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). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 10, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- 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 |