FDA Inspection 1010191 — Wysong Corporation
The FDA completed an inspection of Wysong Corporation on May 2, 2017 in Midland, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 2, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Midland, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15552 | 21 CFR 111.260(j)(2) | Batch record - initials; each step |
| 15558 | 21 CFR 111.260(k)(1) | Batch record - identifier; packaging |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 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 |
| 15898 | 21 CFR 111.83(b)(1) | Reserve sample -container-closure system |