Atlas

Form 483

Reproductive Services Of Indiana, Inc Form 483, 2014-11-05

FDA issued a Form 483 to Reproductive Services Of Indiana, Inc on 2014-11-05 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Reproductive Services Of Indiana, Inc · Carmel, United States · Issued November 5, 2014

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.

5 Nov 2014
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Ifueko Osemwota

5 Nov 2014
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Ifueko Osemwota

5 Nov 2014
21 CFR 1271.55(d)(2)

Accurate, indelible, legible

Cited by Ifueko Osemwota

Inspected site

RSReproductive Services Of Indiana, IncCarmel, United States

Inspection team

IOIfueko Osemwota

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 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(d)(2)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