College Pharmacy Incorporated
Form 483 issued March 15, 2013 · Colorado Springs, Colorado
- Inspection
- Mar 5 – Mar 15, 2013
- Investigators
- Matthew R. Dionne· Zachery L. Miller
- Observations
- 6
- Pages
- 8
- FEI number
- 1000117234
In short: On March 15, 2013, FDA issued a Form 483 with 6 observations to College Pharmacy Incorporated in Colorado Springs, Colorado (FEI 1000117234) after an inspection that ran Mar 5 – Mar 15, 2013. The investigators were Matthew R. Dionne and Zachery L. Miller. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls 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
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Each lot of a component liable to objectionable microbiological contamination is deficiently subjected to…
- 04
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include…
This inspection in context
Matthew R. Dionne
2 documents · 2009–2013
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Colorado.
The firmCollege Pharmacy Incorporated history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at College Pharmacy Incorporated?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected College Pharmacy Incorporated?
Matthew R. Dionne and Zachery L. Miller are named on this Form 483, for the inspection of Mar 5 – Mar 15, 2013. Each investigator has a profile showing what they cite most.
When was College Pharmacy Incorporated inspected by FDA?
The inspection ran Mar 5 – Mar 15, 2013, and the Form 483 is dated March 15, 2013.
How do I get the full Form 483 for College Pharmacy Incorporated?
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.