FDA Inspection 1123115 — Sperian Eye & Face Protection Inc
The FDA completed an inspection of Sperian Eye & Face Protection Inc on April 8, 2020 in Platteville, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 8, 2020
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Platteville, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |