FDA-Inspected Site

California Pharmacy & Compounding Center

5 FDA inspections are on record for California Pharmacy & Compounding Center in Newport Beach, United States.

483· Form 483 issued

Newport Beach, United States · Last updated July 9, 2026

Overview

  • 5 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-12-17.

At a glance

Inspections

5

Form 483s

5

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
6 Dec 2018 – 17 Dec 2018Human Drugs483View 483 →
27 Mar 2017 – 21 Apr 2017Human Drugs483View 483 →
2 Aug 2016 – 31 Aug 2016Human Drugs483On file
14 Oct 2014 – 17 Oct 2014Human DrugsWLView 483 →
18 Aug 2014 – 25 Aug 2014Human Drugs483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

17 Dec 2018
FDCA 501(a)(2)(A)

Hazardous drugs, prevention of cross-contamination

Cited by Linda Thai, Mariza M Jafary

21 Apr 2017
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Darren S Brown

21 Apr 2017
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Darren S Brown

21 Apr 2017
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Darren S Brown

21 Apr 2017
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Darren S Brown

Investigators

FDA investigators tied to this site in the record.

Linda Thai2 insp.
Ademola O Daramola2 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations4x
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.125(a)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)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 211.186(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)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 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind California Pharmacy & Compounding Center's 5 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat