Form 483

California Pharmacy & Compounding Center Form 483, 2018-12-17

FDA issued a Form 483 to California Pharmacy & Compounding Center on 2018-12-17 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

California Pharmacy & Compounding Center · Newport Beach, United States · Issued December 17, 2018

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Hazardous drugs, prevention of cross-contamination

Cited by Linda Thai, Mariza M Jafary

Inspected site

CPCalifornia Pharmacy & Compounding CenterNewport Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 501(a)(2)(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 1 observation

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