Isomeric Pharmacy Solution, LLC
Form 483 issued June 29, 2016 · Salt Lake City, Utah
- Inspection
- Jun 20 – Jun 29, 2016
- Investigators
- Jamie L. Dion· Zachery L. Miller
- Observations
- 9
- Pages
- 11
- FEI number
- 3011752429
In short: On June 29, 2016, FDA issued a Form 483 with 9 observations to Isomeric Pharmacy Solution, LLC in Salt Lake City, Utah (FEI 3011752429) after an inspection that ran Jun 20 – Jun 29, 2016. The investigators were Jamie L. Dion and Zachery L. Miller. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
An adequate number of batches of each drug product are not tested to determine…
- 03
Time limits are not established when appropriate for the completion of each production phase to assure…
- 04
Deviations from written production and process control…
This inspection in context
Jamie L. Dion
11 documents · 2013–2019
Cites 211.42 (design and construction features) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Isomeric Pharmacy Solution, LLC?
FDA listed 9 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Isomeric Pharmacy Solution, LLC?
Jamie L. Dion and Zachery L. Miller are named on this Form 483, for the inspection of Jun 20 – Jun 29, 2016. Each investigator has a profile showing what they cite most.
When was Isomeric Pharmacy Solution, LLC inspected by FDA?
The inspection ran Jun 20 – Jun 29, 2016, and the Form 483 is dated June 29, 2016.
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.