FDA Inspection
Hologic, Inc.Hologic, Inc. – FDA Inspection, Jul 16, 2009
Record Details
This FDA Inspection record concerns Hologic, Inc., with an inspection on July 16, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Hologic, Inc.
- Inspection Date
- July 16, 2009
- Product Type
- Biologics
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ID · e86a9dba-8bcc-47d5-8f08-1ce0d14a6ef3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 599118
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
12- 21 CFR 820.70(b)Verification or validation of changes
- 21 CFR 820.198(a)(1)Uniform and timely processing
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.120(c)Storage
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.150(a)Storage procedures to prevent mix-ups
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures
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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 |
| October 14, 2022 | OAI | 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 |
Other documents for Hologic, Inc.
- FDA Inspection 1252605 - 2024-08-13
- FDA Inspection 1181513 - 2022-10-14
- FDA Inspection 1076849 - 2018-12-10
- FDA Inspection 998474 - 2016-12-07
- FDA Inspection 977288 - 2016-06-30
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