Atlas

Form 483

Pacific Reproductive Center, Inc. Form 483, 2015-07-06

FDA issued a Form 483 to Pacific Reproductive Center, Inc. on 2015-07-06 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Pacific Reproductive Center, Inc. · Irvine, United States · Issued July 6, 2015

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.

6 Jul 2015
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Tawny L Colling

6 Jul 2015
21 CFR 1271.50(b)(2)

Donor testing not negative for CD agents

Cited by Tawny L Colling

6 Jul 2015
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Tawny L Colling

Inspected site

PRPacific Reproductive Center, Inc.Irvine, United States

Inspection team

TLTawny L Colling

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.50(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1271.50(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(a)(1)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