Atlas

Form 483

Hemagen Diagnostics Inc Form 483, 2018-01-10

FDA issued a Form 483 to Hemagen Diagnostics Inc on 2018-01-10 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Hemagen Diagnostics Inc · Baltimore, United States · Issued January 10, 2018

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.

10 Jan 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by James M Simpson

10 Jan 2018
21 CFR 820.120

Lack of or inadequate procedures for labeling

Cited by James M Simpson

10 Jan 2018
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by James M Simpson

Inspected site

HDHemagen Diagnostics IncBaltimore, United States

Inspection team

JMJames M Simpson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.120Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited 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