Atlas

FDA-Inspected Site

Cubist Pharmaceuticals, Inc.

9 FDA inspections are on record for Cubist Pharmaceuticals, Inc. in Lexington, United States.

Clean· No action indicated

Lexington, United States · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2014-09-04.

At a glance

Inspections

9

Form 483s

7

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 Aug 2014 – 4 Sep 2014Human DrugsClean
29 May 2014 – 10 Jul 2014Human Drugs483On file
29 Jul 2013 – 20 Aug 2013Human Drugs483View 483 →
18 Mar 2013 – 26 Mar 2013Human Drugs483View 483 →
9 Dec 2011Not recorded483On file
15 Dec 2010Not recorded483View 483 →
31 Aug 2009Not recorded483View 483 →
4 Apr 2008Not recorded483On file
14 Nov 2006Not recordedClean

Observations on record

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

20 Aug 2013
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Stacey S Degarmo, Philip Kreiter, Ramon E Martinez

20 Aug 2013
21 CFR 211.198(a)

Procedures to be written and followed

Cited by Stacey S Degarmo, Philip Kreiter, Ramon E Martinez

20 Aug 2013
21 CFR 314.81(b)(1)(ii)

Contamination, chemical or physical change, deterioration

Cited by Stacey S Degarmo, Philip Kreiter, Ramon E Martinez

26 Mar 2013
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Justine M Corson

15 Dec 2010
21 CFR 211.198(a)

Procedures to be written and followed

Cited by Stacey S Degarmo, Aireen V Mendoza

Investigators

FDA investigators tied to this site in the record.

Stacey S Degarmo3 insp.
Ramon E Martinez2 insp.
Kenneth H Williams2 insp.
Paraluman S Leonin2 insp.
Matthew C Watson1 insp.
Mary-Jeanet Mcgarry1 insp.
Philip Kreiter1 insp.
Justine M Corson1 insp.
Aireen V Mendoza1 insp.
Megan A Haggerty1 insp.
Rory Geyer1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Cubist Pharmaceuticals, Inc.'s 7 Form 483s

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