Atlas

FDA-Inspected Site

Bristol Myers Squibb Manufacturing Company

13 FDA inspections are on record for Bristol Myers Squibb Manufacturing Company in Humacao, United States.

Clean· No action indicated

Humacao, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2020-02-14.

At a glance

Inspections

13

Form 483s

4

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Feb 2020 – 14 Feb 2020Human DrugsClean
16 Apr 2018 – 27 Apr 2018Human Drugs483View 483 →
14 Nov 2016 – 18 Nov 2016Human Drugs483View 483 →
30 Nov 2015 – 9 Dec 2015Human DrugsClean
29 Jan 2014 – 20 Feb 2014Human Drugs483View 483 →
2 Feb 2012Not recordedClean
9 Mar 2011Not recordedClean
25 Jun 2010Not recorded483On file
25 Jun 2008Not recordedClean
18 Feb 2005Not recordedClean
8 Aug 2002Not recordedClean
16 May 2001Not recordedClean

Observations on record

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

27 Apr 2018
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Noreen Muniz

27 Apr 2018
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Noreen Muniz

27 Apr 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Noreen Muniz

27 Apr 2018
21 CFR 211.25(a)

GMP Training Frequency

Cited by Noreen Muniz

18 Nov 2016
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Noreen Muniz

Investigators

FDA investigators tied to this site in the record.

Libia M Lugo3 insp.
Noreen Muniz2 insp.
Rebecca Rodriguez2 insp.
Miguel A Martinez2 insp.
Jose F Velez1 insp.
Rakhi B Shah1 insp.
Jose E Melendez1 insp.
Marianela Aponte Cruz1 insp.
Adalberto Cajigas1 insp.
Lourdes Andujar1 insp.
Ramon A Hernandez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.188Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Bristol Myers Squibb Manufacturing Company'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