Isomeric Pharmacy Solutions, LLC
Form 483 issued March 24, 2017 · Salt Lake City, Utah
- Inspection
- Feb 22 – Mar 24, 2017
- Investigator
- Zachary L. Stamm
- Observations
- 14
- Pages
- 15
- FEI number
- 3011752
In short: On March 24, 2017, FDA issued a Form 483 with 14 observations to Isomeric Pharmacy Solutions, LLC in Salt Lake City, Utah (FEI 3011752) after an inspection that ran Feb 22 – Mar 24, 2017. The investigator was Zachary L. Stamm. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Procedures describing the handling of all written and oral complaints regarding a drug…
- 03
An adequate number of batches of each drug product are not tested to determine…
- 04
Deviations from written production and process control procedures are…
This inspection in context
Zachary L. Stamm
13 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmIsomeric Pharmacy Solutions, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Isomeric Pharmacy Solutions, LLC?
FDA listed 14 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Isomeric Pharmacy Solutions, LLC?
Zachary L. Stamm is named on this Form 483, for the inspection of Feb 22 – Mar 24, 2017. Each investigator has a profile showing what they cite most.
When was Isomeric Pharmacy Solutions, LLC inspected by FDA?
The inspection ran Feb 22 – Mar 24, 2017, and the Form 483 is dated March 24, 2017.
How do I get the full Form 483 for Isomeric Pharmacy Solutions, 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.