Warning letter
Hologic, Inc.: warning letter of Dec 18, 2024
FDA warning letter 698214 · Center for Devices and Radiological Health
Key facts
| Reference number | 698214 |
|---|---|
| Company | Hologic, Inc. |
| Subject | CGMP/QSR/Medical Devices/Adulterated/Misbranded |
| Issue date | Dec 18, 2024 |
| Posted date | Jan 14, 2025 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 7, 803, 803.3, 806, 806.10, 803.50(a)(1), 806.2(j), 820 |
| Inspection city | Marlborough |
| Inspection ZIP | 01752 |
| Inspection start date | Jul 30, 2024 |
| 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: