Central Admixture Pharmacy Services, Inc.
Form 483 issued March 7, 2013 · Homewood, Alabama
- Inspection
- Mar 4 – Mar 7, 2013
- Investigators
- Marie A. Fadden· Paul C. Mouris
- Observations
- 12
- Pages
- 4
- FEI number
- 1000221951
In short: On March 7, 2013, FDA issued a Form 483 with 12 observations to Central Admixture Pharmacy Services, Inc. in Homewood, Alabama (FEI 1000221951) after an inspection that ran Mar 4 – Mar 7, 2013. The investigators were Marie A. Fadden and Paul C. Mouris. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 8 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Investigations of an unexplained discrepancy did not extend to other drug products that may have been…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
Marie A. Fadden
8 documents · 2004–2015
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Wisconsin.
The firmCentral Admixture Pharmacy Services, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(b)
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 12 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc.?
Marie A. Fadden and Paul C. Mouris are named on this Form 483, for the inspection of Mar 4 – Mar 7, 2013. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Mar 4 – Mar 7, 2013, and the Form 483 is dated March 7, 2013.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc.?
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.