FDA Inspection 838567 — Windmill Health Products, LLC
The FDA completed an inspection of Windmill Health Products, LLC on Jul 17, 2013 in West Caldwell, NJ. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 17, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- West Caldwell, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15847 | 21 CFR 111.73 | Specifications met - component identity |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15946 | 21 CFR 111.105(i) | QC - required operations returned dietary supplements |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |
| 15995 | 21 CFR 111.127(d) | Quality control operations - packaged, labeled; specifications |