Form 483

Central Admixture Pharmacy Services, Inc. Form 483, 2014-06-11

FDA issued a Form 483 to Central Admixture Pharmacy Services, Inc. on 2014-06-11 with 10 public-safe observations.

483· Form 483 issuedHuman Drugs10 observations

Central Admixture Pharmacy Services, Inc. · Allentown, United States · Issued June 11, 2014

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

11 Jun 2014
21 CFR 211.28(a)

Clothing appropriate for duties performed

Cited by Anita R Michael

11 Jun 2014
21 CFR 211.42(b)

Product flow through building is inadequate

Cited by Anita R Michael

11 Jun 2014
21 CFR 211.42(c)

Defined areas of adequate size for operations

Cited by Anita R Michael

11 Jun 2014
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Anita R Michael

11 Jun 2014
21 CFR 211.84(a)

Components withheld from use pending release

Cited by Anita R Michael

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 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(a)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 10 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