Atlas

Form 483

Delaware Valley OB/GYN & Infertility Group P.C. Form 483, 2013-07-30

FDA issued a Form 483 to Delaware Valley OB/GYN & Infertility Group P.C. on 2013-07-30 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Delaware Valley OB/GYN & Infertility Group P.C. · Lawrenceville, United States · Issued July 30, 2013

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.

30 Jul 2013
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Jonee J Mearns

30 Jul 2013
21 CFR 1271.47(b)

Review and approval of procedures

Cited by Jonee J Mearns

30 Jul 2013
21 CFR 1271.75(a)(1)

Risk factors, clinical evidence

Cited by Jonee J Mearns

Inspected site

DVDelaware Valley OB/GYN & Infertility Group P.C.Lawrenceville, United States

Inspection team

JJJonee J Mearns

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.47(b)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