Form 483

SHS International, Ltd. dba Nutricia Liverpool Form 483, 2015-09-24

FDA issued a Form 483 to SHS International, Ltd. dba Nutricia Liverpool on 2015-09-24 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

SHS International, Ltd. dba Nutricia Liverpool · Liverpool, United Kingdom · Issued September 24, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

24 Sep 2015
21 CFR 110.20(b)(6)

Fans/air blowing equipment

Cited by Brian R Yaun

24 Sep 2015
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Brian R Yaun

24 Sep 2015
21 CFR 110.40(g)

Compressed air/gases

Cited by Brian R Yaun

24 Sep 2015
21 CFR 110.80

Reasonable precautions

Cited by Brian R Yaun

24 Sep 2015
21 CFR 110.80(b)(13)

Filling, assembling, packing controls

Cited by Brian R Yaun

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.40(g)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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