Atlas

Form 483

Reproductive Gynecology Laboratories Form 483, 2013-01-15

FDA issued a Form 483 to Reproductive Gynecology Laboratories on 2013-01-15 with 2 public-safe observations.

483· Form 483 issued2 observations

Reproductive Gynecology Laboratories · Akron, United States · Issued January 15, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

15 Jan 2013
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Nancy L Neiger

15 Jan 2013
21 CFR 1271.55(d)(2)

Accurate, indelible, legible

Cited by Nancy L Neiger

Inspected site

RGReproductive Gynecology LaboratoriesAkron, United States

Inspection team

NLNancy L Neiger

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 1271.55(d)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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