Atlas

Form 483

Huvepharma, Inc. Form 483, 2012-02-21

FDA issued a Form 483 to Huvepharma, Inc. on 2012-02-21 with 3 public-safe observations.

483· Form 483 issued3 observations

Huvepharma, Inc. · Longmont, United States · Issued February 21, 2012

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.

21 Feb 2012
21 CFR 226.1

Automated equipment - assurance of proper performance

Cited by Kimberley A Hoefen

21 Feb 2012
21 CFR 226.30

Design suitable to facilitate maintenance and operation

Cited by Kimberley A Hoefen

21 Feb 2012
21 CFR 226.40(e)

Cleaning to prevent contamination of Type A articles

Cited by Kimberley A Hoefen

Inspected site

HIHuvepharma, Inc.Longmont, United States

Inspection team

KAKimberley A Hoefen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 226.1Cited across public-safe Form 483 observations1x
21 CFR 226.30Cited across public-safe Form 483 observations1x
21 CFR 226.40(e)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