Form 483

Central Admixture Pharmacy Services Inc Form 483, 2018-09-11

FDA issued a Form 483 to Central Admixture Pharmacy Services Inc on 2018-09-11 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Central Admixture Pharmacy Services Inc · San Diego, United States · Issued September 11, 2018

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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 Sep 2018
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Joey V Quitania

11 Sep 2018
21 CFR 211.186(a)

Written procedures followed

Cited by Joey V Quitania

11 Sep 2018
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Joey V Quitania

11 Sep 2018
21 CFR 211.42(c)(10)

Aseptic Processing Area

Cited by Joey V Quitania

11 Sep 2018
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Joey V Quitania

Inspected site

CACentral Admixture Pharmacy Services IncSan Diego, United States

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 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.80(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 6 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