Atlas

Form 483

Hillestad Pharmaceuticals USA, Inc. Form 483, 2019-06-20

FDA issued a Form 483 to Hillestad Pharmaceuticals USA, Inc. on 2019-06-20 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Hillestad Pharmaceuticals USA, Inc. · Woodruff, United States · Issued June 20, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 2 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.

20 Jun 2019
21 CFR 111.27(d)

Equipment - maintain - general

Cited by Jesse P Romenesko

20 Jun 2019
21 CFR 111.353

Manufacturing operations - written procedures

Cited by Jesse P Romenesko

20 Jun 2019
21 CFR 111.353

Manufacturing operations - written procedures

Cited by Jesse P Romenesko

Inspected site

HPHillestad Pharmaceuticals USA, Inc.Woodruff, United States

Inspection team

JPJesse P Romenesko

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.353Cited across public-safe Form 483 observations2x
21 CFR 111.27(d)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