Isomeric Pharmacy Solution, LLC
FDA inspection history in Salt Lake City, Utah, 2015 to 2016
- 2
- Form 483s
- 1
- Warning letter
- 1
- Response
Every document, by year
- Warning letter
- Form 483
- Response
2015: one 483 response and one Form 483; 2016: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16Two Form 483s, one 483 response and one warning letter, at Salt Lake City, Utah.
- 2016The longest 483 on file: 9 observations over 11 pages at Salt Lake City, Utah.
Cited most
Across all Isomeric Pharmacy Solution observations on file
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.166Stability testing2
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.111Time limitations on production1
The complete Isomeric Pharmacy Solution file.
All 4 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
Salt Lake City, Utah
Two Form 483s, one warning letter and one 483 response · 2015 to 2016 · 14 observations
Latest: Warning letter, Dec 12, 2016 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-12-12 | Warning letter Warning letter | Salt Lake City, Utah | — | $99 |
| 2016-06-29 | 483 Form 483 | Salt Lake City, Utah | 9 | $99 |
| 2015-09-17 | Response 483 response | Salt Lake City, Utah | — | $199 |
| 2015-08-28 | 483 Form 483 | Salt Lake City, Utah | 5 | $99 |
Investigators on these documents
Erika V. Butler (2)Zachery L. Miller (2)Jamie L. Dion (1)Zachary L. Miller (1)
FEI number 3011752429 · most recent document Dec 12, 2016
About Isomeric Pharmacy Solution, LLC
How many FDA Form 483s has Isomeric Pharmacy Solution, LLC received?
FDA Intel has 2 Form 483s on file for Isomeric Pharmacy Solution, LLC; the most recent is dated Jun 29, 2016.
When was Isomeric Pharmacy Solution, LLC last inspected by FDA?
The most recent FDA inspection document on file for Isomeric Pharmacy Solution, LLC is a Form 483 dated Jun 29, 2016, for the site in Salt Lake City, Utah.
What did FDA cite at Isomeric Pharmacy Solution, LLC?
The regulations cited most in the observations on file for Isomeric Pharmacy Solution, LLC are 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.166 (Stability testing), 2 times; 21 CFR 211.42 (Design and construction features), 2 times.
Has Isomeric Pharmacy Solution, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Isomeric Pharmacy Solution, LLC; the most recent is dated Dec 12, 2016.