FDA Inspection
Hologic, Inc.Hologic, Inc. – FDA Inspection, May 20, 2009
Record Details
This FDA Inspection record concerns Hologic, Inc., with an inspection on May 20, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hologic, Inc.
- Inspection Date
- May 20, 2009
- Product Type
- Devices
View Company Profile
ID · 565aa19a-570f-4cf4-9950-3ea4dce5415e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 585539
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.184(d)Acceptance records
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