FDA Inspection 1096651 — Wei Laboratories, Inc.
The FDA completed an inspection of Wei Laboratories, Inc. on July 17, 2019 in Santa Clara, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 17, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Santa Clara, CA (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 |
| 15562 | 21 CFR 111.260(l)(1) | Batch record - quality control review; production |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15890 | 21 CFR 111.80(a) | Components packaging, labels used |
| 15970 | 21 CFR 111.120 | Quality control operations - components, packaging, labels |