California Pharmacy & Compounding Center
Form 483 issued August 25, 2014 · Newport Beach, California
- Inspection
- Aug 18 – Aug 25, 2014
- Investigators
- Ademola O. Daramola· Binh T. Nguyen
- Observations
- 15
- Pages
- 14
- FEI number
- 3004600090
In short: On August 25, 2014, FDA issued a Form 483 with 15 observations to California Pharmacy & Compounding Center in Newport Beach, California (FEI 3004600090) after an inspection that ran Aug 18 – Aug 25, 2014. The investigators were Ademola O. Daramola and Binh T. Nguyen. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 03
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Ademola O. Daramola
11 documents · 2014–2018
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
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(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at California Pharmacy & Compounding Center?
FDA listed 15 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?
Ademola O. Daramola and Binh T. Nguyen are named on this Form 483, for the inspection of Aug 18 – Aug 25, 2014. Each investigator has a profile showing what they cite most.
When was California Pharmacy & Compounding Center inspected by FDA?
The inspection ran Aug 18 – Aug 25, 2014, and the Form 483 is dated August 25, 2014.
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.