Hologic, Inc.

Form 483

Bedford, Massachusetts, United StatesFEI 1221300Issued June 03, 2016

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1221300.

Observations2

Issue DateJune 03, 2016

Status1 Related Warning Letter

Related Inspections4

Establishment Details

Firm: Hologic, Inc.
Location: Bedford, Massachusetts, United States
FEI Number: 1221300
Product Type: Devices
Issue Date: June 03, 2016
Country: United States

Inspection History, 2011 to 2016

NAI2

VAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

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Hologic, Inc. FDA Form 483, Bedford, Massachusetts, June 3, 2016