Enemeez, LLC dba Summit Pharmaceuticals
Form 483 issued February 12, 2026 · Phoenix, Arizona
- Inspection
- Feb 2 – Feb 12, 2026
- Investigator
- Jeffrey T. Prosterman
- Observations
- 5
- Pages
- 5
- FEI number
- 3005641023
In short: On February 12, 2026, FDA issued a Form 483 with 5 observations to Enemeez, LLC dba Summit Pharmaceuticals in Phoenix, Arizona (FEI 3005641023) after an inspection that ran Feb 2 – Feb 12, 2026. The investigator was Jeffrey T. Prosterman. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Written records of investigations into unexplained discrepancies do not include…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Component testing is deficient in that each component is not tested for conformity with all appropriate…
This inspection in context
Jeffrey T. Prosterman
5 documents · 2025–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Arizona.
The firmEnemeez, LLC dba Summit Pharmaceuticals history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Enemeez, LLC dba Summit Pharmaceuticals?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Enemeez, LLC dba Summit Pharmaceuticals?
Jeffrey T. Prosterman is named on this Form 483, for the inspection of Feb 2 – Feb 12, 2026. Each investigator has a profile showing what they cite most.
When was Enemeez, LLC dba Summit Pharmaceuticals inspected by FDA?
The inspection ran Feb 2 – Feb 12, 2026, and the Form 483 is dated February 12, 2026.
How do I get the full Form 483 for Enemeez, LLC dba Summit Pharmaceuticals?
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.