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Form 483

Unity Fertility Center, LLC Form 483, 2021-09-02

FDA issued a Form 483 to Unity Fertility Center, LLC on 2021-09-02 with 9 public-safe observations.

483· Form 483 issuedBiologics9 observations

Unity Fertility Center, LLC · Pasadena, United States · Issued September 2, 2021

Overview

  • 9 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.

2 Sep 2021
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Ka L Wong

2 Sep 2021
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Ka L Wong

2 Sep 2021
21 CFR 1271.50(a)

Responsible person to determine, document

Cited by Ka L Wong

2 Sep 2021
21 CFR 1271.50(a)

Responsible person to determine, document

Cited by Ka L Wong

2 Sep 2021
21 CFR 1271.85(b)(2)

SOP for release; reactive for CMV

Cited by Ka L Wong

Inspected site

UFUnity Fertility Center, LLCPasadena, United States

Inspection team

KLKa L Wong

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 1271.50(a)Cited across public-safe Form 483 observations3x
21 CFR 1271.85(b)(2)Cited across public-safe Form 483 observations3x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 9 observations

The source PDF, 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