Isomeric Pharmacy Solution, LLC
Form 483 issued August 28, 2015 · Salt Lake City, Utah
- Inspection
- Aug 24 – Aug 28, 2015
- Investigators
- Erika V. Butler· Zachery L. Miller
- Observations
- 5
- Pages
- 4
- FEI number
- 3011752429
In short: On August 28, 2015, FDA issued a Form 483 with 5 observations to Isomeric Pharmacy Solution, LLC in Salt Lake City, Utah (FEI 3011752429) after an inspection that ran Aug 24 – Aug 28, 2015. The investigators were Erika V. Butler and Zachery L. Miller. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is no written testing program designed to assess the stability…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmIsomeric Pharmacy Solution, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Isomeric Pharmacy Solution, LLC?
FDA listed 5 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 Isomeric Pharmacy Solution, LLC?
Erika V. Butler and Zachery L. Miller are named on this Form 483, for the inspection of Aug 24 – Aug 28, 2015. Each investigator has a profile showing what they cite most.
When was Isomeric Pharmacy Solution, LLC inspected by FDA?
The inspection ran Aug 24 – Aug 28, 2015, and the Form 483 is dated August 28, 2015.
How do I get the full Form 483 for Isomeric Pharmacy Solution, 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.