Atlas

Form 483

Nesher Pharmaceuticals (USA) LLC Form 483, 2009-02-02

FDA issued a Form 483 to Nesher Pharmaceuticals (USA) LLC on 2009-02-02 with 35 public-safe observations.

483· Form 483 issued35 observations

Nesher Pharmaceuticals (USA) LLC · Saint Louis, United States · Issued February 2, 2009

Overview

  • 35 public-safe observations are available for this inspection.
  • 31 structured CFR citations are represented.
  • 19 investigators are tied to this Form 483.

Inspectional observations

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

2 Feb 2009
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Matthew J Morrison, Shanna R Haden, Eric C Nielsen, Kathleen B Swat, Carmen Y Fisher, Sheri L Stephenson, Joseph R Lambert, Kara L Roden, Samuel K Gibbons, Shirley J Berryman, Michele Perry Williams, William C Corley, Jessica L Peterson, Warren J Lopicka, Gwyn G Dickinson, Sarah E Morris, Tara L Breckenridge, Patrick L Wisor, Jennifer Cahill

2 Feb 2009
21 CFR 211.42(b)

Adequate space lacking to prevent mix-ups and contamination

Cited by Matthew J Morrison, Shanna R Haden, Eric C Nielsen, Kathleen B Swat, Carmen Y Fisher, Sheri L Stephenson, Joseph R Lambert, Kara L Roden, Samuel K Gibbons, Shirley J Berryman, Michele Perry Williams, William C Corley, Jessica L Peterson, Warren J Lopicka, Gwyn G Dickinson, Sarah E Morris, Tara L Breckenridge, Patrick L Wisor, Jennifer Cahill

2 Feb 2009
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Matthew J Morrison, Shanna R Haden, Eric C Nielsen, Kathleen B Swat, Carmen Y Fisher, Sheri L Stephenson, Joseph R Lambert, Kara L Roden, Samuel K Gibbons, Shirley J Berryman, Michele Perry Williams, William C Corley, Jessica L Peterson, Warren J Lopicka, Gwyn G Dickinson, Sarah E Morris, Tara L Breckenridge, Patrick L Wisor, Jennifer Cahill

2 Feb 2009
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Matthew J Morrison, Shanna R Haden, Eric C Nielsen, Kathleen B Swat, Carmen Y Fisher, Sheri L Stephenson, Joseph R Lambert, Kara L Roden, Samuel K Gibbons, Shirley J Berryman, Michele Perry Williams, William C Corley, Jessica L Peterson, Warren J Lopicka, Gwyn G Dickinson, Sarah E Morris, Tara L Breckenridge, Patrick L Wisor, Jennifer Cahill

2 Feb 2009
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Matthew J Morrison, Shanna R Haden, Eric C Nielsen, Kathleen B Swat, Carmen Y Fisher, Sheri L Stephenson, Joseph R Lambert, Kara L Roden, Samuel K Gibbons, Shirley J Berryman, Michele Perry Williams, William C Corley, Jessica L Peterson, Warren J Lopicka, Gwyn G Dickinson, Sarah E Morris, Tara L Breckenridge, Patrick L Wisor, Jennifer Cahill

Inspected site

NPNesher Pharmaceuticals (USA) LLCSaint Louis, United States

Inspection team

MJMatthew J Morrison
SRShanna R Haden
ECEric C Nielsen
KBKathleen B Swat
CYCarmen Y Fisher
SLSheri L Stephenson
JRJoseph R Lambert
KLKara L Roden
SKSamuel K Gibbons
SJShirley J Berryman
MPMichele Perry Williams
WCWilliam C Corley
JLJessica L Peterson
WJWarren J Lopicka
GGGwyn G Dickinson
SESarah E Morris
TLTara L Breckenridge
PLPatrick L Wisor
JCJennifer Cahill

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations5x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.105(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130(d)Cited across public-safe Form 483 observations1x
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(11)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.194(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(d)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.204Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.86Cited across public-safe Form 483 observations1x
21 CFR 211.89Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(2)(iv)(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 35 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