Atlas

Form 483

SDI Diagnostics, Inc. Form 483, 2011-04-29

FDA issued a Form 483 to SDI Diagnostics, Inc. on 2011-04-29 with 6 public-safe observations.

483· Form 483 issued6 observations

SDI Diagnostics, Inc. · South Easton, United States · Issued April 29, 2011

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

29 Apr 2011
21 CFR 820.25(b)

Training records

Cited by Philip H Lafleur

29 Apr 2011
21 CFR 820.70(g)(1)

Maintenance schedule, Lack of or inadequate schedule

Cited by Philip H Lafleur

29 Apr 2011
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Philip H Lafleur

29 Apr 2011
21 CFR 820.140

Lack of or inadequate procedures for handling

Cited by Philip H Lafleur

29 Apr 2011
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Philip H Lafleur

Inspected site

SDSDI Diagnostics, Inc.South Easton, United States

Inspection team

PHPhilip H Lafleur

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.140Cited across public-safe Form 483 observations1x
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.70(g)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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