Form 483

Central Admixture Pharmacy Services, Inc. Form 483, 2023-03-30

FDA issued a Form 483 to Central Admixture Pharmacy Services, Inc. on 2023-03-30 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Central Admixture Pharmacy Services, Inc. · Allentown, United States · Issued March 30, 2023

Overview

  • 6 public-safe observations are available for this inspection.
  • 5 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.

30 Mar 2023
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Jazmine N Brown

30 Mar 2023
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jazmine N Brown

30 Mar 2023
21 CFR 211.167(a)

Sterility/pyrogen-free testing

Cited by Jazmine N Brown

30 Mar 2023
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Jazmine N Brown

30 Mar 2023
21 CFR 211.192

Written record of investigation incomplete

Cited by Jazmine N Brown

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.167(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)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 6 observations

The source PDF, 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