Atlas

Form 483

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company Form 483, 2010-03-31

FDA issued a Form 483 to Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company on 2010-03-31 with 4 public-safe observations.

483· Form 483 issued4 observations

Bristol-Myers Squibb Holdings Pharma Ltd. Liability Company · Manati, United States · Issued March 31, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

31 Mar 2010
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jose E Melendez

31 Mar 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Jose E Melendez

31 Mar 2010
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Jose E Melendez

31 Mar 2010
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jose E Melendez

Inspected site

BSBristol-Myers Squibb Holdings Pharma Ltd. Liability CompanyManati, United States

Inspection team

JEJose E Melendez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere