Atlas

Form 483

Texas Center for Reproductive Health Form 483, 2016-02-04

FDA issued a Form 483 to Texas Center for Reproductive Health on 2016-02-04 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

Texas Center for Reproductive Health · Dallas, United States · Issued February 4, 2016

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

4 Feb 2016
21 CFR 1271.90(b)

Eligibility not required--warning labels

Cited by Yaw O Osei

4 Feb 2016
21 CFR 1271.90(b)(1)

Autologous use only--labeling

Cited by Yaw O Osei

4 Feb 2016
21 CFR 1271.90(c)

Eligibility not required--warning labels

Cited by Yaw O Osei

4 Feb 2016
21 CFR 1271.90(c)(1)

Autologous use only--labeling

Cited by Yaw O Osei

Inspected site

TCTexas Center for Reproductive HealthDallas, United States

Inspection team

YOYaw O Osei

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.90(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.90(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.90(c)Cited across public-safe Form 483 observations1x
21 CFR 1271.90(c)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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