Form 483

Pluromed, Inc. Form 483, 2012-10-09

FDA issued a Form 483 to Pluromed, Inc. on 2012-10-09 with 2 public-safe observations.

483· Form 483 issued2 observations

Pluromed, Inc. · Woburn, United States · Issued October 9, 2012

Overview

2 public-safe observations are available for this inspection.
2 structured CFR citations are represented.
2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Oct 2012

21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Justine M Corson, Lauren M Lawrance

9 Oct 2012

21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Justine M Corson, Lauren M Lawrance

Inspected site

PIPluromed, Inc.Woburn, United States

Inspection team

JMJustine M Corson

LMLauren M Lawrance

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 820.100(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.198(a)	Cited across public-safe Form 483 observations	1x

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