California Pharmacy & Compounding Center
Form 483 issued October 17, 2014 · Newport Beach, California
- Inspection
- Oct 14 – Oct 17, 2014
- Investigators
- Ademola O. Daramola· Binh T. Nguyen· Liming Zhang
- Observations
- 3
- Pages
- 3
- FEI number
- 3004600090
In short: On October 17, 2014, FDA issued a Form 483 with 3 observations to California Pharmacy & Compounding Center in Newport Beach, California (FEI 3004600090) after an inspection that ran Oct 14 – Oct 17, 2014. The investigators were Ademola O. Daramola, Binh T. Nguyen and Liming Zhang. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.125(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written records of investigations into the failure of a batch or any of its components to…
- 03
Strict control is not exercised over labeling issued for use in…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at California Pharmacy & Compounding Center?
FDA listed 3 observations on this Form 483, mostly about quality system and packaging & labeling. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected California Pharmacy & Compounding Center?
Ademola O. Daramola, Binh T. Nguyen and Liming Zhang are named on this Form 483, for the inspection of Oct 14 – Oct 17, 2014. Each investigator has a profile showing what they cite most.
When was California Pharmacy & Compounding Center inspected by FDA?
The inspection ran Oct 14 – Oct 17, 2014, and the Form 483 is dated October 17, 2014.
How do I get the full Form 483 for California Pharmacy & Compounding Center?
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