FDA Inspection 1327538 — Fuller Industries Inc
The FDA completed an inspection of Fuller Industries Inc on Jul 23, 2026 in Great Bend, KS. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jul 23, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Great Bend, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1843 | 21 CFR 211.84(d)(2) | Component written specification |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |