Atlas

Form 483

Manhattan Reproductive Medicine, PC Form 483, 2010-01-14

FDA issued a Form 483 to Manhattan Reproductive Medicine, PC on 2010-01-14 with 2 public-safe observations.

483· Form 483 issued2 observations

Manhattan Reproductive Medicine, PC · New York, United States · Issued January 14, 2010

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.

14 Jan 2010
21 CFR 1271.47(a)

Procedures for all other requirements

Cited by Amy W Yan Mai

14 Jan 2010
21 CFR 1271.55(d)(2)

Accurate, indelible, legible

Cited by Amy W Yan Mai

Inspected site

MRManhattan Reproductive Medicine, PCNew York, United States

Inspection team

AWAmy W Yan Mai

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