Form 483

Central Illinois Compounding, Inc. dba Preckshot Professiona Form 483, 2015-05-14

FDA issued a Form 483 to Central Illinois Compounding, Inc. dba Preckshot Professiona on 2015-05-14 with 11 public-safe observations.

483· Form 483 issuedHuman Drugs11 observations

Central Illinois Compounding, Inc. dba Preckshot Professiona · Peoria Heights, United States · Issued May 14, 2015

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

14 May 2015
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Russell K Riley

14 May 2015
21 CFR 211.165(a)

Testing and release for distribution

Cited by Russell K Riley

14 May 2015
21 CFR 211.165(e)

Test methods

Cited by Russell K Riley

14 May 2015
21 CFR 211.166(a)

Lack of written stability program

Cited by Russell K Riley

14 May 2015
21 CFR 211.167(a)

Sterility/pyrogen-free testing

Cited by Russell K Riley

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.167(a)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)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 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.94(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 11 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