Nesher Pharmaceuticals (USA) LLC, Saint Louis: FDA Inspections, Form 483s & Citations

Overview

18 FDA inspections are on record.
9 inspections produced a Form 483.
The most recent recorded inspection date is 2021-08-12.

At a glance

Inspections

Form 483s

EIRs

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

Inspection	Category	Outcome	Form 483
9 Aug 2021 – 12 Aug 2021	Human Drugs	483	On file
13 May 2019 – 31 May 2019	Human Drugs	483	On file
23 Jan 2017 – 3 Feb 2017	Human Drugs	483	On file
22 Apr 2015 – 7 May 2015	Human Drugs	483	View 483 →
29 Oct 2013 – 7 Nov 2013	Human Drugs	Clean
6 Dec 2012	Not recorded	483	On file
11 Feb 2011	Not recorded	483	On file
2 Feb 2009	Not recorded	483	View 483 →
28 Aug 2008	Not recorded	483	On file
26 Mar 2008	Not recorded	483	On file
20 Apr 2007	Not recorded	Clean
23 Mar 2006	Not recorded	Clean
28 Jan 2005	Not recorded	Clean
23 Jan 2004	Not recorded	Clean
29 Apr 2003	Not recorded	Clean
2 Nov 2001	Not recorded	Clean
16 Mar 2001	Not recorded	Clean
3 Mar 2000	Not recorded	Clean

Observations on record

Form 483 observations cited at this site, most recent first.

7 May 2015

21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Robert J Ham, Michele Perry-Williams, Michele Perry Williams

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

2 Feb 2009

21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

2 Feb 2009

21 CFR 211.67(b)

Written procedures not established/followed

Investigators

FDA investigators tied to this site in the record.

Michele Perry-Williams3 insp.

Michele Perry Williams3 insp.

Robert J Ham2 insp.

Tara L Breckenridge2 insp.

Alan M Barker1 insp.

Wayne D Mcgrath1 insp.

Kellia N Hicks1 insp.

Dawn C Olenjack1 insp.

Shafiq Ahadi1 insp.

Eric M Mueller1 insp.

Verlinda A Narcisse1 insp.

Adree N Anderson1 insp.

Matthew J Morrison1 insp.

Shanna R Haden1 insp.

Eric C Nielsen1 insp.

Kathleen B Swat1 insp.

Carmen Y Fisher1 insp.

Sheri L Stephenson1 insp.

Joseph R Lambert1 insp.

Kara L Roden1 insp.

Samuel K Gibbons1 insp.

Shirley J Berryman1 insp.

William C Corley1 insp.

Jessica L Peterson1 insp.

Warren J Lopicka1 insp.

Gwyn G Dickinson1 insp.

Sarah E Morris1 insp.

Patrick L Wisor1 insp.

Jennifer Cahill1 insp.

Farhana Khan1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

Citation	What it covers	Cited
21 CFR 211.192	Cited across public-safe Form 483 observations	5x
21 CFR 211.100(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.100(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.105(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.110(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.130(d)	Cited across public-safe Form 483 observations	1x
21 CFR 211.130(e)	Cited across public-safe Form 483 observations	1x
21 CFR 211.160(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.160(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.166(a)(4)	Cited across public-safe Form 483 observations	1x
21 CFR 211.182	Cited across public-safe Form 483 observations	1x
21 CFR 211.188(b)(11)	Cited across public-safe Form 483 observations	1x
21 CFR 211.194(a)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 211.194(a)(4)	Cited across public-safe Form 483 observations	1x
21 CFR 211.194(a)(8)	Cited across public-safe Form 483 observations	1x
21 CFR 211.194(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.194(d)	Cited across public-safe Form 483 observations	1x
21 CFR 211.198(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.204	Cited across public-safe Form 483 observations	1x
21 CFR 211.22(d)	Cited across public-safe Form 483 observations	1x
21 CFR 211.42(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.46(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.67(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.67(b)	Cited across public-safe Form 483 observations	1x
21 CFR 211.67(b)(3)	Cited across public-safe Form 483 observations	1x
21 CFR 211.67(c)	Cited across public-safe Form 483 observations	1x
21 CFR 211.68(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.84(d)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 211.86	Cited across public-safe Form 483 observations	1x
21 CFR 211.89	Cited across public-safe Form 483 observations	1x
21 CFR 314.81(b)(1)(ii)	Cited across public-safe Form 483 observations	1x
21 CFR 314.81(b)(2)(iv)(b)	Cited across public-safe Form 483 observations	1x

Full site report

Get the verbatim findings behind Nesher Pharmaceuticals (USA) LLC's 9 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

The site's full inspection history, with every Form 483 and its outcome
Warning letters and recalls tied to the company behind it
Whether recurring CFR citations get closed out or repeat

Nesher Pharmaceuticals (USA) LLC

Overview

At a glance

Inspection history

Observations on record

Equipment for Environmental Control

Procedures not in writing, fully followed

Adequate space lacking to prevent mix-ups and contamination

Cleaning / Sanitizing / Maintenance

Written procedures not established/followed

Cleaning SOPs/instructions

Cleaning/maintenance records not kept

Calibration/Inspection/Checking not done

Reports of Analysis (Components)

Rotation of components/containers/closures

Quarantine of Rejected Components et. al.

Changes to Procedures Not Reviewed, Approved

SOPs not followed / documented

Identification of containers, lines, equipment

Control procedures to monitor and validate performance

Examination of packaging and labeling

Packaging line inspection before use

Following/documenting laboratory controls

Scientifically sound laboratory controls

Testing in same container - closure system

Written records kept in individual logs

Identification of persons involved, each significant step

Extent of discrepancy, failure investigations

Investigations of discrepancies, failures

No written record of investigation

Quality control unit review of records

Written record of investigation incomplete

Laboratory Test Method Verification

Complete Test Data

Second person sign off

Test method modification records not maintained

Laboratory equipment calibration records

Procedures to be written and followed

Returned drug products with doubt cast as to safety et. al.

Failure to meet specifications

Mfg and control changes not requiring a supplemental app.

Investigators

Recurring citations

Get the verbatim findings behind Nesher Pharmaceuticals (USA) LLC's 9 Form 483s