Form 483

New England Donor Services, Inc. Form 483, 2010-10-15

FDA issued a Form 483 to New England Donor Services, Inc. on 2010-10-15 with 1 public-safe observation.

483· Form 483 issued1 observation

New England Donor Services, Inc. · Waltham, United States · Issued October 15, 2010

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Oct 2010
21 CFR 1271.190(d)(1)

Description of methods, schedule

Cited by Kent A Conforti

Inspected site

NENew England Donor Services, Inc.Waltham, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.190(d)(1)Cited across public-safe Form 483 observations1x

Full 483 report

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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