Form 483

Mid-Continent Packaging, LLC Form 483, 2013-01-24

FDA issued a Form 483 to Mid-Continent Packaging, LLC on 2013-01-24 with 12 public-safe observations.

483· Form 483 issued12 observations

Mid-Continent Packaging, LLC · Enid, United States · Issued January 24, 2013

Overview

  • 12 public-safe observations are available for this inspection.
  • 12 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.

24 Jan 2013
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Margaret M Annes

24 Jan 2013
21 CFR 211.84(d)(2)

Reports of Analysis (Components)

Cited by Margaret M Annes

24 Jan 2013
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Margaret M Annes

24 Jan 2013
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Margaret M Annes

24 Jan 2013
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Margaret M Annes

Inspected site

MPMid-Continent Packaging, LLCEnid, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.184(c)Cited across public-safe Form 483 observations1x
21 CFR 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 12 observations

The source PDF and 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