Form 483

Kendal Nutricare Ltd. Form 483, 2024-06-21

FDA issued a Form 483 to Kendal Nutricare Ltd. on 2024-06-21 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Kendal Nutricare Ltd. · Kendal, United Kingdom · Issued June 21, 2024

Overview

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

Inspectional observations

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

21 Jun 2024
21 CFR 106.20(a)

Maintain building in clean, sanitary condition

Cited by Elizabeth P Mayer, Danny Tuntevski, Gale L Glinecki

21 Jun 2024
21 CFR 106.20(f)(3)

Potable water - representative samples frequency

Cited by Elizabeth P Mayer, Danny Tuntevski, Gale L Glinecki

21 Jun 2024
21 CFR 106.30(e)(5)

Thermal process - frequency, monitor temperature

Cited by Elizabeth P Mayer, Danny Tuntevski, Gale L Glinecki

21 Jun 2024
21 CFR 106.55(a)

System of process controls to prevent adulteration

Cited by Elizabeth P Mayer, Danny Tuntevski, Gale L Glinecki

Inspected site

KNKendal Nutricare Ltd.Kendal, United Kingdom

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 106.20(a)Cited across public-safe Form 483 observations1x
21 CFR 106.20(f)(3)Cited across public-safe Form 483 observations1x
21 CFR 106.30(e)(5)Cited across public-safe Form 483 observations1x
21 CFR 106.55(a)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF, 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