Central Admixture Pharmacy Services Inc.
Form 483 issued January 21, 2016 · Valley View, Ohio
- Inspection
- Oct 26, 2015 – Jan 21, 2016
- Investigators
- Michael P. Sheehan· Nicholas L. Paulin
- Observations
- 5
- Pages
- 4
- FEI number
- 3003693389
In short: On January 21, 2016, FDA issued a Form 483 with 5 observations to Central Admixture Pharmacy Services Inc. in Valley View, Ohio (FEI 3003693389) after an inspection that ran Oct 26, 2015 – Jan 21, 2016. The investigators were Michael P. Sheehan and Nicholas L. Paulin. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Clothing of personnel engaged in the processing of drug products is not appropriate for…
This inspection in context
Michael P. Sheehan
6 documents · 2011–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmCentral Admixture Pharmacy Services Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(a)
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 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services Inc.?
Michael P. Sheehan and Nicholas L. Paulin are named on this Form 483, for the inspection of Oct 26, 2015 – Jan 21, 2016. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services Inc. inspected by FDA?
The inspection ran Oct 26, 2015 – Jan 21, 2016, and the Form 483 is dated January 21, 2016.
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.