FDA Inspection 1292502 — Spartan Chemical Co Inc
The FDA completed an inspection of Spartan Chemical Co Inc on November 21, 2025 in Maumee, OH. 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
- November 21, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Maumee, OH (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2567 | 21 CFR 211.198(a) | Adverse Drug Experience |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |