Edge Pharmacy Services, LLC
Form 483 issued November 30, 2021 · Colchester, Vermont
- Inspection
- Sep 20 – Nov 30, 2021
- Investigators
- Erik W. Koester· Sean R. Marcsisin
- Observations
- 13
- Pages
- 28
- FEI number
- 3010490167
In short: On November 30, 2021, FDA issued a Form 483 with 13 observations to Edge Pharmacy Services, LLC in Colchester, Vermont (FEI 3010490167) after an inspection that ran Sep 20 – Nov 30, 2021. The investigators were Erik W. Koester and Sean R. Marcsisin. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and laboratory controls account for 9 of 13 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Test procedures relative to appropriate laboratory testing for sterility are…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edge Pharmacy Services, LLC?
FDA listed 13 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. 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 Edge Pharmacy Services, LLC?
Erik W. Koester and Sean R. Marcsisin are named on this Form 483, for the inspection of Sep 20 – Nov 30, 2021. Each investigator has a profile showing what they cite most.
When was Edge Pharmacy Services, LLC inspected by FDA?
The inspection ran Sep 20 – Nov 30, 2021, and the Form 483 is dated November 30, 2021.
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.