One Way Drug, LLC dba Partell Specialty Pharmacy
FDA inspection history in Las Vegas, Nevada, 2014 to 2017
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one Form 483; 2015: one warning letter; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–17Two Form 483s and one warning letter, at Las Vegas, Nevada.
- 2014The longest 483 on file: 7 observations over 5 pages at Las Vegas, Nevada.
Cited most
Across all One Way Drug, LLC dba Partell Specialty Pharmacy observations on file
- 21 CFR 211.165(a)Testing and release for distribution3
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.198(a)Complaint files1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete One Way Drug, LLC dba Partell Specialty Pharmacy file.
All 3 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
Las Vegas, Nevada
Two Form 483s and one warning letter · 2014 to 2017 · 10 observations
Latest: Form 483, Jul 19, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-07-19 | 483 Form 483 | Las Vegas, Nevada | 3 | $99 |
| 2015-07-22 | Warning letter Warning letter | Las Vegas, Nevada | — | $99 |
| 2014-05-30 | 483 Form 483 | Las Vegas, Nevada | 7 | $99 |
Investigators on these documents
Ashar P. Parikh (1)Eileen A. Liu (1)Jennifer H. Rhyu (1)Kristin M. Abaonza (1)Rumany C. Penn (1)
FEI number 3010839113 · most recent document Jul 19, 2017
About One Way Drug, LLC dba Partell Specialty Pharmacy
How many FDA Form 483s has One Way Drug, LLC dba Partell Specialty Pharmacy received?
FDA Intel has 2 Form 483s on file for One Way Drug, LLC dba Partell Specialty Pharmacy; the most recent is dated Jul 19, 2017.
When was One Way Drug, LLC dba Partell Specialty Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for One Way Drug, LLC dba Partell Specialty Pharmacy is a Form 483 dated Jul 19, 2017, for the site in Las Vegas, Nevada.
What did FDA cite at One Way Drug, LLC dba Partell Specialty Pharmacy?
The regulations cited most in the observations on file for One Way Drug, LLC dba Partell Specialty Pharmacy are 21 CFR 211.165(a) (Testing and release for distribution), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has One Way Drug, LLC dba Partell Specialty Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for One Way Drug, LLC dba Partell Specialty Pharmacy; the most recent is dated Jul 22, 2015.