Atlas

Form 483

PeaceHealth Siuslaw Region Form 483, 2011-07-20

FDA issued a Form 483 to PeaceHealth Siuslaw Region on 2011-07-20 with 1 public-safe observation.

483· Form 483 issued1 observation

PeaceHealth Siuslaw Region · Florence, United States · Issued July 20, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Jul 2011
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Rebecca T Davis

Inspected site

PSPeaceHealth Siuslaw RegionFlorence, United States

Inspection team

RTRebecca T Davis

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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