Company
United StatesHologic, Inc., San Diego, CA – FDA Inspections
Inspection records and compliance data for Hologic, Inc. in San Diego, California. 18 FDA inspections on record (1 OAI), last inspected August 13, 2024.
Company Profile
This profile covers Hologic, Inc. based in San Diego, California, United States.
FDA Inspection History
- FDA inspections
- 18
- OAI
- 1
- VAI
- 5
- NAI
- 12
- Form 483s
- 0
- Warning letters
- 0
First inspected July 16, 2009. Last inspected August 13, 2024.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design validation - production units1 inspection
- Documentation1 inspection
FDA inspections (18)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 13, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1252605 |
| October 14, 2022 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1181513 |
| December 10, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1076849 |
| December 7, 2016 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 998474 |
| June 30, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 977288 |
| January 22, 2016 | NAI | Biologics · Blood and Blood Products | 958896 |
| September 11, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 943992 |
| April 10, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 922618 |
| December 18, 2013 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 857172 |
| May 24, 2013 | VAI | Biologics · Blood and Blood Products | 833293 |
| January 25, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 817352 |
| January 25, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 817333 |
| January 25, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 817300 |
| March 29, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 773082 |
| March 18, 2011 | NAI | Biologics · Blood and Blood Products | 716348 |
| December 2, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 704432 |
| September 21, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 616281 |
| July 16, 2009 | VAI | Biologics · Blood and Blood Products | 599118 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hologic, Inc.
FEI Number
2024800
Address
10210 Genetic Center Dr, San Diego, California 92121, United States
Country
United States
ID: e60542f3-3b14-4264-802f-9828d3aaf5e1