California Pharmacy & Compounding Center
Form 483 issued December 17, 2020 · Newport Beach, California
- Inspection
- Dec 6, 2018 – Dec 17, 2020
- Investigator
- Linda Thai
- Observations
- 1
- Pages
- 1
- FEI number
- 3004600090
In short: On December 17, 2020, 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, 2018 – Dec 17, 2020. The investigator was Linda Thai. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×) · 211.42 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced hazardous drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils…
This 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 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at California Pharmacy & Compounding Center?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). 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, 2018 – Dec 17, 2020. Each investigator has a profile showing what they cite most.
When was California Pharmacy & Compounding Center inspected by FDA?
The inspection ran Dec 6, 2018 – Dec 17, 2020, and the Form 483 is dated December 17, 2020.
How do I get the full Form 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.