California Pharmacy & Compounding Center
Amended 483 issued December 18, 2018 · Newport Beach, California
- Inspection
- Dec 6 – Dec 17, 2018
- Investigator
- Linda Thai
- Observations
- 1
- Pages
- 1
- FEI number
- 3004600090
In short: On December 18, 2018, FDA issued a Amended 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- 01FDCA 501(a)(2)(A)
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils…
The full amended 483
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
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 firmCalifornia Pharmacy & Compounding Center history
All 8 documents on file for this site, in date order, with what was cited at each inspection.
Similar documentsMore amended 483s
Browse other documents of this type.
Questions about this amended 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 Amended 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 Amended 483 is dated December 18, 2018.
How do I get the full Amended 483 for California Pharmacy & Compounding Center?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.