Atlas

Form 483

Institute For Women's Health - Advanced Fertility Center Form 483, 2014-06-05

FDA issued a Form 483 to Institute For Women's Health - Advanced Fertility Center on 2014-06-05 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Institute For Women's Health - Advanced Fertility Center · San Antonio, United States · Issued June 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 Jun 2014
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Maira P Brading

5 Jun 2014
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Maira P Brading

5 Jun 2014
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Maira P Brading

Inspected site

IFInstitute For Women's Health - Advanced Fertility CenterSan Antonio, United States

Inspection team

MPMaira P Brading

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 1271.75(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.90(c)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