FDA Inspection
Hologic, Inc.Hologic, Inc. – FDA Inspection, Oct 14, 2022
Record Details
This FDA Inspection record concerns Hologic, Inc., with an inspection on October 14, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hologic, Inc.
- Inspection Date
- October 14, 2022
- Product Type
- Devices
View Company Profile
ID · eefc0758-29d8-4906-a458-de2cea123468
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1181513
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.30(g)Design validation - production units
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Other FDA inspections of Hologic, Inc.
17| Date | Classification | Office | Project area |
|---|---|---|---|
| August 13, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 10, 2018 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 7, 2016 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| June 30, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 22, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Hologic, Inc.
- FDA Inspection 1252605 - 2024-08-13
- FDA Inspection 1076849 - 2018-12-10
- FDA Inspection 998474 - 2016-12-07
- FDA Inspection 977288 - 2016-06-30
- FDA Inspection 958896 - 2016-01-22
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