Atlas

Form 483

Huron Medical Center Form 483, 2012-03-09

FDA issued a Form 483 to Huron Medical Center on 2012-03-09 with 2 public-safe observations.

483· Form 483 issued2 observations

Huron Medical Center · Bad Axe, United States · Issued March 9, 2012

Overview

  • 2 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.

9 Mar 2012
21 CFR 606.100(b)

Establish, maintain and follow manufacturing SOPs

Cited by Barbara A Rusin

9 Mar 2012
21 CFR 606.100(b)(15)

Schedules and procedures for equipment & calibration

Cited by Barbara A Rusin

Inspected site

HMHuron Medical CenterBad Axe, United States

Inspection team

BABarbara A Rusin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)(15)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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