Form 483

M W Laboratories Inc Form 483, 2008-11-04

FDA issued a Form 483 to M W Laboratories Inc on 2008-11-04 with 25 public-safe observations.

483· Form 483 issued25 observations

M W Laboratories Inc · Savannah, United States · Issued November 4, 2008

Overview

  • 25 public-safe observations are available for this inspection.
  • 24 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.

4 Nov 2008
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Brandy Davis Brown

4 Nov 2008
21 CFR 211.25(a)

GMP Training Frequency

Cited by Brandy Davis Brown

4 Nov 2008
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Brandy Davis Brown

4 Nov 2008
21 CFR 211.56(c)

Written procedures lacking for use of pesticides etc.

Cited by Brandy Davis Brown

4 Nov 2008
21 CFR 211.80(a)

Procedures To Be in Writing

Cited by Brandy Davis Brown

Inspected site

MWM W Laboratories IncSavannah, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.182Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.122(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.150Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(b)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(11)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(c)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 25 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