Enemeez, LLC dba Summit Pharmaceuticals
FDA inspection history in Phoenix, Arizona, 2021 to 2026
- 2
- Form 483s
Every document, by year
- Form 483
2021: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2021One Form 483, at Phoenix, Arizona.
- 2026One Form 483, at Phoenix, Arizona.
- 2026The longest 483 on file: 5 observations over 5 pages at Phoenix, Arizona.
Cited most
Across all Enemeez, LLC dba Summit Pharmaceuticals observations on file
- 21 CFR 211.166(a)Stability testing3
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165(a)Testing and release for distribution1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
The complete Enemeez, LLC dba Summit Pharmaceuticals file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Phoenix, Arizona
Two Form 483s · 2021 to 2026 · 8 observations
Latest: Form 483, Feb 12, 2026 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-02-12 | 483 Form 483 | Phoenix, Arizona | 5 | $99 |
| 2021-07-29 | 483 Form 483 | Phoenix, Arizona | 3 | $99 |
Investigators on these documents
James B. Arnett (1)Jeffrey T. Prosterman (1)Joel D. Hustedt (1)
FEI number 3005641023 · most recent document Feb 12, 2026
About Enemeez, LLC dba Summit Pharmaceuticals
How many FDA Form 483s has Enemeez, LLC dba Summit Pharmaceuticals received?
FDA Intel has 2 Form 483s on file for Enemeez, LLC dba Summit Pharmaceuticals; the most recent is dated Feb 12, 2026.
When was Enemeez, LLC dba Summit Pharmaceuticals last inspected by FDA?
The most recent FDA inspection document on file for Enemeez, LLC dba Summit Pharmaceuticals is a Form 483 dated Feb 12, 2026, for the site in Phoenix, Arizona.
What did FDA cite at Enemeez, LLC dba Summit Pharmaceuticals?
The regulations cited most in the observations on file for Enemeez, LLC dba Summit Pharmaceuticals are 21 CFR 211.166(a) (Stability testing), 3 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165(a) (Testing and release for distribution), 1 time.