Atlas

Form 483

Reproductive Services Of Indiana, Inc Form 483, 2018-05-10

FDA issued a Form 483 to Reproductive Services Of Indiana, Inc on 2018-05-10 with 5 public-safe observations.

483· Form 483 issuedBiologics5 observations

Reproductive Services Of Indiana, Inc · Carmel, United States · Issued May 10, 2018

Overview

  • 5 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 May 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Lewis K Antwi

10 May 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Lewis K Antwi

10 May 2018
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Lewis K Antwi

10 May 2018
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Lewis K Antwi

10 May 2018
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Lewis K Antwi

Inspected site

RSReproductive Services Of Indiana, IncCarmel, United States

Inspection team

LKLewis K Antwi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations3x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 5 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