College Pharmacy Incorporated
Form 483 issued May 28, 2015 · Colorado Springs, Colorado
- Inspection
- May 11 – May 28, 2015
- Investigators
- Jamie L. Dion· Michael A. Charles
- Observations
- 7
- Pages
- 4
- FEI number
- 1000117234
In short: On May 28, 2015, FDA issued a Form 483 with 7 observations to College Pharmacy Incorporated in Colorado Springs, Colorado (FEI 1000117234) after an inspection that ran May 11 – May 28, 2015. The investigators were Jamie L. Dion and Michael A. Charles. 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
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Regardless oftbe number of…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Test procedures relative to appropriate laboratory testing for…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) 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(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at College Pharmacy Incorporated?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 College Pharmacy Incorporated?
Jamie L. Dion and Michael A. Charles are named on this Form 483, for the inspection of May 11 – May 28, 2015. Each investigator has a profile showing what they cite most.
When was College Pharmacy Incorporated inspected by FDA?
The inspection ran May 11 – May 28, 2015, and the Form 483 is dated May 28, 2015.
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.