Atlas

Form 483

VWR Advanced Instruments, LLC Form 483, 2011-04-08

FDA issued a Form 483 to VWR Advanced Instruments, LLC on 2011-04-08 with 3 public-safe observations.

483· Form 483 issued3 observations

VWR Advanced Instruments, LLC · Manati, United States · Issued April 8, 2011

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

8 Apr 2011
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Libia M Lugo

8 Apr 2011
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Libia M Lugo

8 Apr 2011
21 CFR 211.194(e)

Stability testing records not included

Cited by Libia M Lugo

Inspected site

VAVWR Advanced Instruments, LLCManati, United States

Inspection team

LMLibia M Lugo

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 211.194(e)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 3 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