One Way Drug, LLC dba Partell Specialty Pharmacy
Form 483 issued July 19, 2017 · Las Vegas, Nevada
- Inspection
- Jul 17 – Jul 19, 2017
- Investigators
- Eileen A. Liu· Kristin M. Abaonza· Rumany C. Penn
- Observations
- 3
- Pages
- 4
- FEI number
- 3010839113
In short: On July 19, 2017, FDA issued a Form 483 with 3 observations to One Way Drug, LLC dba Partell Specialty Pharmacy in Las Vegas, Nevada (FEI 3010839113) after an inspection that ran Jul 17 – Jul 19, 2017. The investigators were Eileen A. Liu, Kristin M. Abaonza and Rumany C. Penn. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Drug products failing to meet established specifications are…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Eileen A. Liu
41 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmOne Way Drug, LLC dba Partell Specialty Pharmacy history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at One Way Drug, LLC dba Partell Specialty Pharmacy?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected One Way Drug, LLC dba Partell Specialty Pharmacy?
Eileen A. Liu, Kristin M. Abaonza and Rumany C. Penn are named on this Form 483, for the inspection of Jul 17 – Jul 19, 2017. Each investigator has a profile showing what they cite most.
When was One Way Drug, LLC dba Partell Specialty Pharmacy inspected by FDA?
The inspection ran Jul 17 – Jul 19, 2017, and the Form 483 is dated July 19, 2017.
How do I get the full Form 483 for One Way Drug, LLC dba Partell Specialty Pharmacy?
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.