California Pharmacy & Compounding Center
Form 483 issued August 31, 2016 · Newport Beach, California
- Inspection
- Aug 2 – Aug 31, 2016
- Investigator
- Linda Thai
- Observations
- 5
- Pages
- 4
- FEI number
- 3004600090
In short: On August 31, 2016, FDA issued a Form 483 with 5 observations to California Pharmacy & Compounding Center in Newport Beach, California (FEI 3004600090) after an inspection that ran Aug 2 – Aug 31, 2016. The investigator was Linda Thai. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 3 of 5 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 04
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at California Pharmacy & Compounding Center?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). 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 Aug 2 – Aug 31, 2016. Each investigator has a profile showing what they cite most.
When was California Pharmacy & Compounding Center inspected by FDA?
The inspection ran Aug 2 – Aug 31, 2016, and the Form 483 is dated August 31, 2016.
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.