California Pharmacy & Compounding Center
Form 483 issued April 21, 2017 · Newport Beach, California
- Inspection
- Mar 27 – Apr 21, 2017
- Investigator
- Darren S. Brown
- Observations
- 7
- Pages
- 5
- FEI number
- 3004600090
In short: On April 21, 2017, FDA issued a Form 483 with 7 observations to California Pharmacy & Compounding Center in Newport Beach, California (FEI 3004600090) after an inspection that ran Mar 27 – Apr 21, 2017. The investigator was Darren S. Brown. 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 5 of 7 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
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 02
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
This inspection in context
Darren S. Brown
27 documents · 2015–2026
Cites 211.42 (design and construction features) 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 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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?
Darren S. Brown is named on this Form 483, for the inspection of Mar 27 – Apr 21, 2017. Each investigator has a profile showing what they cite most.
When was California Pharmacy & Compounding Center inspected by FDA?
The inspection ran Mar 27 – Apr 21, 2017, and the Form 483 is dated April 21, 2017.
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.