Atlas

Form 483

Manhattan Fertility Services LLC Form 483, 2016-04-11

FDA issued a Form 483 to Manhattan Fertility Services LLC on 2016-04-11 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

Manhattan Fertility Services LLC · New York, United States · Issued April 11, 2016

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.

11 Apr 2016
21 CFR 1271.47(a)

Donor eligibility procedures

Cited by Evelyn Taha

11 Apr 2016
21 CFR 1271.55(a)(3)

Summary--records used to make determination

Cited by Evelyn Taha

11 Apr 2016
21 CFR 1271.80(b)

Specimen collections not timely

Cited by Evelyn Taha

11 Apr 2016
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Evelyn Taha

Inspected site

MFManhattan Fertility Services LLCNew York, United States

Inspection team

ETEvelyn Taha

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.47(a)Cited across public-safe Form 483 observations2x
21 CFR 1271.55(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 1271.80(b)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