Central Admixture Pharmacy Services, Inc.
Form 483 issued February 22, 2013 · Chicago, Illinois
- Inspection
- Feb 19 – Feb 22, 2013
- Investigators
- Bruce H. McCullough· Russell K. Riley
- Observations
- 7
- Pages
- 3
- FEI number
- 1000305893
In short: On February 22, 2013, FDA issued a Form 483 with 7 observations to Central Admixture Pharmacy Services, Inc. in Chicago, Illinois (FEI 1000305893) after an inspection that ran Feb 19 – Feb 22, 2013. The investigators were Bruce H. McCullough and Russell K. Riley. 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
There is a failure to thoroughly review the failure ofa batch or any of its components…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
There was a failure to handle and store components at all times in a…
This inspection in context
Bruce H. McCullough
2 documents · 2013
Cites 211.42(c)(10)(iii) (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
The firmCentral Admixture Pharmacy Services, Inc. history
The site's inspection history, in date order.
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 Central Admixture Pharmacy Services, Inc.?
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 Central Admixture Pharmacy Services, Inc.?
Bruce H. McCullough and Russell K. Riley are named on this Form 483, for the inspection of Feb 19 – Feb 22, 2013. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Feb 19 – Feb 22, 2013, and the Form 483 is dated February 22, 2013.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc.?
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