Form 483

VVF Illinois Services LLC Form 483, 2015-07-27

FDA issued a Form 483 to VVF Illinois Services LLC on 2015-07-27 with 10 public-safe observations.

483· Form 483 issuedHuman Drugs10 observations

VVF Illinois Services LLC · Montgomery, United States · Issued July 27, 2015

Overview

  • 10 public-safe observations are available for this inspection.
  • 5 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.

27 Jul 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Brian D Nicholson

27 Jul 2015
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Brian D Nicholson

27 Jul 2015
21 CFR 211.194(a)(4)

Data secured in course of each test

Cited by Brian D Nicholson

27 Jul 2015
21 CFR 211.22(a)

Approve or reject components, products

Cited by Brian D Nicholson

27 Jul 2015
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Brian D Nicholson

Inspected site

VIVVF Illinois Services LLCMontgomery, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.22(a)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 10 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