Enemeez, LLC dba Summit Pharmaceuticals
Form 483 issued July 29, 2021 · Phoenix, Arizona
- Inspection
- Jul 26 – Jul 29, 2021
- Investigators
- James B. Arnett· Joel D. Hustedt
- Observations
- 3
- Pages
- 3
- FEI number
- 3005641023
In short: On July 29, 2021, FDA issued a Form 483 with 3 observations to Enemeez, LLC dba Summit Pharmaceuticals in Phoenix, Arizona (FEI 3005641023) after an inspection that ran Jul 26 – Jul 29, 2021. The investigators were James B. Arnett and Joel D. Hustedt. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
3 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The written stability program for drug products does not…
- 02
The written stability program for drug products does not describe the storage conditions for…
- 03
The written stability testing…
This inspection in context
James B. Arnett
2 documents · 2021–2022
Cites 211.166(a) (stability testing) 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 211.166(a)(3)
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 3 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Enemeez, LLC dba Summit Pharmaceuticals?
James B. Arnett and Joel D. Hustedt are named on this Form 483, for the inspection of Jul 26 – Jul 29, 2021. Each investigator has a profile showing what they cite most.
When was Enemeez, LLC dba Summit Pharmaceuticals inspected by FDA?
The inspection ran Jul 26 – Jul 29, 2021, and the Form 483 is dated July 29, 2021.
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.