Edge Pharmacy Services, LLC
FDA inspection history in Colchester, Vermont, 2014 to 2021
- 5
- Form 483s
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
2014: one Form 483; 2015: one close-out letter; 2017: one Form 483; 2018: one Form 483; 2020: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–21Five Form 483s and one close-out letter, at Colchester, Vermont.
- 2020The longest 483 on file: 14 observations over 17 pages at Colchester, Vermont.
Cited most
Across all Edge Pharmacy Services observations on file
- 21 CFR 211.42Design and construction features10
- 21 CFR 211.68Automatic, mechanical, and electronic equipment5
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.166Stability testing4
- 21 CFR 211.167Special testing requirements4
The complete Edge Pharmacy Services file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Colchester, Vermont
Five Form 483s and one close-out letter · 2014 to 2021 · 51 observations
Latest: Form 483, Nov 30, 2021 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-30 | 483 Form 483 | Colchester, Vermont | 13 | $99 |
| 2020-03-30 | 483 Form 483 | Colchester, Vermont | 14 | $99 |
| 2018-03-08 | 483 Form 483 | Colchester, Vermont | 14 | $99 |
| 2017-01-20 | 483 Form 483 | Colchester, Vermont | 4 | $99 |
| 2015-11-12 | Close-out Close-out letter | Colchester, Vermont | — | $99 |
| 2014-08-20 | 483 Form 483 | Colchester, Vermont | 6 | $99 |
Investigators on these documents
Edmund F. Mrak (2)Erik W. Koester (2)John P. Mistler (1)Jonah S. Ufferfilge (1)Niketa Patel (1)Rachael Moliver (1)Samir C. Gala (1)Sean R. Marcsisin (1)
FEI number 3010490167 · most recent document Nov 30, 2021
About Edge Pharmacy Services, LLC
How many FDA Form 483s has Edge Pharmacy Services, LLC received?
FDA Intel has 5 Form 483s on file for Edge Pharmacy Services, LLC; the most recent is dated Nov 30, 2021.
When was Edge Pharmacy Services, LLC last inspected by FDA?
The most recent FDA inspection document on file for Edge Pharmacy Services, LLC is a Form 483 dated Nov 30, 2021, for the site in Colchester, Vermont.
What did FDA cite at Edge Pharmacy Services, LLC?
The regulations cited most in the observations on file for Edge Pharmacy Services, LLC are 21 CFR 211.42 (Design and construction features), 10 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times.