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Form 483

MP Biomedicals Diagnostics Division Form 483, 2011-12-15

FDA issued a Form 483 to MP Biomedicals Diagnostics Division on 2011-12-15 with 1 public-safe observation.

483· Form 483 issued1 observation

MP Biomedicals Diagnostics Division · Solon, United States · Issued December 15, 2011

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 Dec 2011
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Allison M Scheck

Inspected site

MBMP Biomedicals Diagnostics DivisionSolon, United States

Inspection team

AMAllison M Scheck

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

The source PDF and 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