Atlas

Form 483

Pacific Reproductive Center, Inc. Form 483, 2018-02-15

FDA issued a Form 483 to Pacific Reproductive Center, Inc. on 2018-02-15 with 5 public-safe observations.

483· Form 483 issuedBiologics5 observations

Pacific Reproductive Center, Inc. · Irvine, United States · Issued February 15, 2018

Overview

  • 5 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

15 Feb 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Laurissa S Flowers, Thanh B Tran

15 Feb 2018
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Laurissa S Flowers, Thanh B Tran

15 Feb 2018
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Laurissa S Flowers, Thanh B Tran

15 Feb 2018
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Laurissa S Flowers, Thanh B Tran

15 Feb 2018
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Laurissa S Flowers, Thanh B Tran

Inspected site

PRPacific Reproductive Center, Inc.Irvine, United States

Inspection team

LSLaurissa S Flowers
TBThanh B Tran

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 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