Warning letter
Medline Industries, LP: warning letter of Mar 18, 2024
FDA warning letter 677545 · Center for Devices and Radiological Health
Key facts
| Reference number | 677545 |
|---|---|
| Company | Medline Industries, LP |
| Subject | CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded |
| Issue date | Mar 18, 2024 |
| Posted date | Mar 19, 2024 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 807.81(b), 807.81(a)(3)(i), 820 |
| Inspection city | Northfield |
| Inspection ZIP | 60093 |
| Inspection start date | Dec 11, 2023 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: