Atlas

FDA-Inspected Site

Millennium Pharmaceuticals Inc.

9 FDA inspections are on record for Millennium Pharmaceuticals Inc. in Cambridge, United States.

Clean· No action indicated

Cambridge, United States · Last updated August 15, 2026

Overview

  • 9 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2016-04-13.

At a glance

Inspections

9

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Mar 2016 – 13 Apr 2016Human DrugsClean
14 Oct 2015 – 21 Oct 2015Human DrugsClean
4 Aug 2014 – 15 Aug 2014Human Drugs483View 483 →
20 Dec 2013 – 23 Dec 2013Human DrugsClean
30 Nov 2012Not recordedClean
16 Dec 2011Not recorded483View 483 →
5 Aug 2009Not recorded483View 483 →
21 Feb 2008Not recorded483On file
28 Feb 2007Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

15 Aug 2014
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Katherine D Adams, Sharon K Thoma, Donna J Clevenger

15 Aug 2014
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Katherine D Adams, Sharon K Thoma, Donna J Clevenger

15 Aug 2014
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Katherine D Adams, Sharon K Thoma, Donna J Clevenger

15 Aug 2014
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Katherine D Adams, Sharon K Thoma, Donna J Clevenger

15 Aug 2014
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Katherine D Adams, Sharon K Thoma, Donna J Clevenger

Investigators

FDA investigators tied to this site in the record.

Matthew C Watson2 insp.
Rory Geyer2 insp.
Robert J Martin1 insp.
Michael P Anthony1 insp.
Anthony W Thomas1 insp.
Katherine D Adams1 insp.
Sharon K Thoma1 insp.
Donna J Clevenger1 insp.
Dell S Moller1 insp.
Ramon E Martinez1 insp.
Gary J Hagan1 insp.
Paraluman S Leonin1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Millennium Pharmaceuticals Inc.'s 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat