Form 483

Southern California Reproductive Center Medical Group PC Form 483, 2011-06-17

FDA issued a Form 483 to Southern California Reproductive Center Medical Group PC on 2011-06-17 with 4 public-safe observations.

483· Form 483 issued4 observations

Southern California Reproductive Center Medical Group PC · Beverly Hills, United States · Issued June 17, 2011

Overview

  • 4 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.

17 Jun 2011
21 CFR 1271.47(a)

Procedures for all other requirements

Cited by Diana L Ayala

17 Jun 2011
21 CFR 1271.50(a)

Determination based on screening and testing

Cited by Diana L Ayala

17 Jun 2011
21 CFR 1271.50(a)

Responsible person to determine, document

Cited by Diana L Ayala

17 Jun 2011
21 CFR 1271.75(d)

Donors with risks not determined ineligible

Cited by Diana L Ayala

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.50(a)Cited across public-safe Form 483 observations2x
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.75(d)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