California Pharmacy & Compounding Center

Form 483 issued December 17, 2018 · Newport Beach, California

Inspection: Dec 6 – Dec 17, 2018
Investigator: Linda Thai
Observations: 1
Pages: 1
FEI number: 3004600090

In short: On December 17, 2018, FDA issued a Form 483 with 1 observation to California Pharmacy & Compounding Center in Newport Beach, California (FEI 3004600090) after an inspection that ran Dec 6 – Dec 17, 2018. The investigator was Linda Thai.

What FDA observed

Preview: the opening words of each observation

01
FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils…

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This inspection in context

The investigator

Linda Thai

18 documents · 2014–2025

Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.

The firm

California Pharmacy & Compounding Center history

All 8 documents on file for this site, in date order, with what was cited at each inspection.

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Questions about this 483

What did FDA find at California Pharmacy & Compounding Center?

FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.

Who inspected California Pharmacy & Compounding Center?

Linda Thai is named on this Form 483, for the inspection of Dec 6 – Dec 17, 2018. Each investigator has a profile showing what they cite most.

When was California Pharmacy & Compounding Center inspected by FDA?

The inspection ran Dec 6 – Dec 17, 2018, and the Form 483 is dated December 17, 2018.

How do I get the full Form 483 for California Pharmacy & Compounding Center?

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