One Way Drug, LLC dba Partell Specialty Pharmacy
Form 483 issued May 30, 2014 · Las Vegas, Nevada
- Inspection
- May 21 – May 30, 2014
- Investigators
- Ashar P. Parikh· Jennifer H. Rhyu
- Observations
- 7
- Pages
- 5
- FEI number
- 3010839113
In short: On May 30, 2014, FDA issued a Form 483 with 7 observations to One Way Drug, LLC dba Partell Specialty Pharmacy in Las Vegas, Nevada (FEI 3010839113) after an inspection that ran May 21 – May 30, 2014. The investigators were Ashar P. Parikh and Jennifer H. Rhyu. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Drug product containers were not sterilized and processed to remove pyrogenic properties to assure that they…
- 04
There is no written testing program designed to assess the stability…
This inspection in context
Ashar P. Parikh
19 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 211.113(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 7 observations on this Form 483, mostly about production, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected One Way Drug, LLC dba Partell Specialty Pharmacy?
Ashar P. Parikh and Jennifer H. Rhyu are named on this Form 483, for the inspection of May 21 – May 30, 2014. 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 May 21 – May 30, 2014, and the Form 483 is dated May 30, 2014.
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.