Form 483

ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THE Form 483, 2017-08-18

FDA issued a Form 483 to ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THE on 2017-08-18 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

ALFRED E. MANN FOUNDATION FOR SCIENTIFIC RESEARCH, THE · Valencia, United States · Issued August 18, 2017

Overview

  • 8 public-safe observations are 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.

18 Aug 2017
21 CFR 820.75(a)

Documentation

Cited by Sean R Moynihan

18 Aug 2017
21 CFR 820.75(a)

Documentation

Cited by Sean R Moynihan

18 Aug 2017
21 CFR 820.75(a)

Documentation

Cited by Sean R Moynihan

18 Aug 2017
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Sean R Moynihan

18 Aug 2017
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Sean R Moynihan

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.75(a)Cited across public-safe Form 483 observations8x

Full 483 report

Get the verbatim text of all 8 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