Central Admixture Pharmacy Services, Inc.
Form 483 issued February 5, 2016 · Irvine, California
- Inspection
- Feb 1 – Feb 5, 2016
- Investigators
- Djamila Harouaka· Lance A. Finnical· Stacie Woods
- Observations
- 2
- Pages
- 2
- FEI number
- 3006616657
In short: On February 5, 2016, FDA issued a Form 483 with 2 observations to Central Admixture Pharmacy Services, Inc. in Irvine, California (FEI 3006616657) after an inspection that ran Feb 1 – Feb 5, 2016. The investigators were Djamila Harouaka, Lance A. Finnical and Stacie Woods. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Investigations of an unexplained discrepancy did not extend to other batches of…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmCentral Admixture Pharmacy Services, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Admixture Pharmacy Services, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc.?
Djamila Harouaka, Lance A. Finnical and Stacie Woods are named on this Form 483, for the inspection of Feb 1 – Feb 5, 2016. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Feb 1 – Feb 5, 2016, and the Form 483 is dated February 5, 2016.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc.?
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