FDA Inspection 1236550 — Enrinity Supplements, Inc.
The FDA completed an inspection of Enrinity Supplements, Inc. on Apr 22, 2024 in Westland, 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
- Apr 22, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Westland, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15450 | 21 CFR 111.15(f)(3) | Plumbing - source of contamination |
| 15451 | 21 CFR 111.15(f)(4) | Plumbing - floor drainage |
| 15471 | 21 CFR 111.20(c)(5) | Physical plant - separate areas - cleaning, sanitizing |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |