Edge Pharmacy Services, LLC
Form 483 issued March 8, 2018 · Colchester, Vermont
- Inspection
- Feb 15 – Mar 8, 2018
- Investigators
- Niketa Patel· Rachael Moliver
- Observations
- 14
- Pages
- 17
- FEI number
- 3010490167
In short: On March 8, 2018, FDA issued a Form 483 with 14 observations to Edge Pharmacy Services, LLC in Colchester, Vermont (FEI 3010490167) after an inspection that ran Feb 15 – Mar 8, 2018. The investigators were Niketa Patel and Rachael Moliver. Most observations concern facilities & equipment and quality system; 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…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Niketa Patel
15 documents · 2016–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
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 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Edge Pharmacy Services, LLC?
FDA listed 14 observations on this Form 483, mostly about facilities & equipment, quality system 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 Edge Pharmacy Services, LLC?
Niketa Patel and Rachael Moliver are named on this Form 483, for the inspection of Feb 15 – Mar 8, 2018. Each investigator has a profile showing what they cite most.
When was Edge Pharmacy Services, LLC inspected by FDA?
The inspection ran Feb 15 – Mar 8, 2018, and the Form 483 is dated March 8, 2018.
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.