Atlas

Form 483

Conceptions Reproductive Associates Form 483, 2009-12-10

FDA issued a Form 483 to Conceptions Reproductive Associates on 2009-12-10 with 2 public-safe observations.

483· Form 483 issued2 observations

Conceptions Reproductive Associates · Highlands Ranch, United States · Issued December 10, 2009

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.

10 Dec 2009
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Linda M Cherry

10 Dec 2009
21 CFR 1271.55(a)(3)

Summary--records used to make determination

Cited by Linda M Cherry

Inspected site

CRConceptions Reproductive AssociatesHighlands Ranch, United States

Inspection team

LMLinda M Cherry

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(a)(3)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