FDA Inspection 1269620 — Medline Industries, LP
The FDA completed an inspection of Medline Industries, LP on July 18, 2025 in Hartland, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 18, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hartland, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1396 | 21 CFR 211.42(c)(2) | Rejected Material Area |
| 1504 | 21 CFR 211.122(d) | Labels and labeling stored separately |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 4404 | 21 CFR 211.194(a)(1) | Sample identification and other information |