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Form 483

Fresenius Kabi USA LLC Form 483, 2015-09-01

FDA issued a Form 483 to Fresenius Kabi USA LLC on 2015-09-01 with 97 public-safe observations.

483· Form 483 issuedHuman Drugs97 observations

Fresenius Kabi USA LLC · Melrose Park, United States · Issued September 1, 2015

Overview

  • 97 public-safe observations are available for this inspection.
  • 58 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.

1 Sep 2015
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Christopher D Leach

1 Sep 2015
21 CFR 211.100(a)

Approval and review of procedures

Cited by Christopher D Leach

1 Sep 2015
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Christopher D Leach

1 Sep 2015
21 CFR 211.100(b)

Procedure Deviations Recorded and Justified

Cited by Christopher D Leach

1 Sep 2015
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Christopher D Leach

Inspected site

FKFresenius Kabi USA LLCMelrose Park, United States

Inspection team

CDChristopher D Leach

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(b)Cited across public-safe Form 483 observations7x
21 CFR 211.198(a)Cited across public-safe Form 483 observations6x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations4x
21 CFR 211.100(a)Cited across public-safe Form 483 observations3x
21 CFR 211.122(a)Cited across public-safe Form 483 observations3x
21 CFR 211.160(a)Cited across public-safe Form 483 observations3x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations3x
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.130(e)Cited across public-safe Form 483 observations2x
21 CFR 211.132(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.167(b)Cited across public-safe Form 483 observations2x
21 CFR 211.167(c)Cited across public-safe Form 483 observations2x
21 CFR 211.176Cited across public-safe Form 483 observations2x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.198(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.198(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.122(g)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.122(g)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.130Cited across public-safe Form 483 observations1x
21 CFR 211.130(a)Cited across public-safe Form 483 observations1x
21 CFR 211.130(b)Cited across public-safe Form 483 observations1x
21 CFR 211.132(b)Cited across public-safe Form 483 observations1x
21 CFR 211.132(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.184(d)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.194(d)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(vi)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.48(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(2)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 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.94(a)Cited across public-safe Form 483 observations1x

Source document

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Full 483 report

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  • The site's full inspection history around this Form 483
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