Form 483

Bureau Veritas Consumer Products Services Inc. Form 483, 2018-02-01

FDA issued a Form 483 to Bureau Veritas Consumer Products Services Inc. on 2018-02-01 with 9 public-safe observations.

483· Form 483 issuedHuman Drugs9 observations

Bureau Veritas Consumer Products Services Inc. · Buffalo, United States · Issued February 1, 2018

Overview

  • 9 public-safe observations are available for this inspection.
  • 8 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.

1 Feb 2018
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Sony Mathews

1 Feb 2018
21 CFR 211.165(b)

Microbiological testing

Cited by Sony Mathews

1 Feb 2018
21 CFR 211.165(e)

Test methods

Cited by Sony Mathews

1 Feb 2018
21 CFR 211.170(a)(3)

Retention times for actives of OTC drugs

Cited by Sony Mathews

1 Feb 2018
21 CFR 211.194(c)

Testing and standardization of standards et. al.

Cited by Sony Mathews

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(b)Cited across public-safe Form 483 observations2x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.170(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.194(c)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)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 9 observations

The full inspection record, as Atlas holds it, 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