Edge Pharmacy Services, LLC
Form 483 issued August 20, 2014 · Colchester, Vermont
- Inspection
- Jul 22 – Aug 20, 2014
- Investigator
- Edmund F. Mrak
- Observations
- 6
- Pages
- 5
- FEI number
- 3010490167
In short: On August 20, 2014, FDA issued a Form 483 with 6 observations to Edge Pharmacy Services, LLC in Colchester, Vermont (FEI 3010490167) after an inspection that ran Jul 22 – Aug 20, 2014. The investigator was Edmund F. Mrak. Most observations concern laboratory controls and production.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Each batch of drug product purporting to be sterile is not laboratory tested to determine…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Edmund F. Mrak
30 documents · 2010–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmEdge Pharmacy Services, LLC history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edge Pharmacy Services, LLC?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Edge Pharmacy Services, LLC?
Edmund F. Mrak is named on this Form 483, for the inspection of Jul 22 – Aug 20, 2014. Each investigator has a profile showing what they cite most.
When was Edge Pharmacy Services, LLC inspected by FDA?
The inspection ran Jul 22 – Aug 20, 2014, and the Form 483 is dated August 20, 2014.
How do I get the full Form 483 for Edge Pharmacy Services, LLC?
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.