FDA Inspection 1265908 — Spencer Specialty Products Inc
The FDA completed an inspection of Spencer Specialty Products Inc on April 4, 2025 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 4, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |