Central Admixture Pharmacy Services, Inc., (CAPS)
Form 483 issued February 28, 2013 · Kansas City, Missouri
- Inspection
- Feb 19 – Feb 27, 2013
- Investigators
- Shirley J. Berryman· Tara L. Breckenridge
- Observations
- 6
- Pages
- 4
- FEI number
- 3003244004
In short: On February 28, 2013, FDA issued a Form 483 with 6 observations to Central Admixture Pharmacy Services, Inc., (CAPS) in Kansas City, Missouri (FEI 3003244004) after an inspection that ran Feb 19 – Feb 27, 2013. The investigators were Shirley J. Berryman and Tara L. Breckenridge. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 02
Procedures designed to prevent m icrobiological contamination of drug products purporting to be sterile are not…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Batch production and control records do not include the specific identification of each batch of component…
This inspection in context
Shirley J. Berryman
7 documents · 2007–2014
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmCentral Admixture Pharmacy Services, Inc., (CAPS) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Admixture Pharmacy Services, Inc., (CAPS)?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services, Inc., (CAPS)?
Shirley J. Berryman and Tara L. Breckenridge are named on this Form 483, for the inspection of Feb 19 – Feb 27, 2013. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc., (CAPS) inspected by FDA?
The inspection ran Feb 19 – Feb 27, 2013, and the Form 483 is dated February 28, 2013.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc., (CAPS)?
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.