One Way Drug LLC dba Partell Specialty Pharmacy
Form 483 issued March 8, 2018 · Las Vegos, Nevada
- Inspection
- Feb 26 – Mar 8, 2018
- Investigators
- Juanita P. Versace· Lucila B. Nwatu
- Observations
- 9
- Pages
- 6
- FEI number
- 3011769075
In short: On March 8, 2018, FDA issued a Form 483 with 9 observations to One Way Drug LLC dba Partell Specialty Pharmacy in Las Vegos, Nevada (FEI 3011769075) after an inspection that ran Feb 26 – Mar 8, 2018. The investigators were Juanita P. Versace and Lucila B. Nwatu. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
5 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (5×) · 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The (b) (4) intended to render final product sterile is not adequate to accomplish sterilization and/or…
- 02
Observation 2: scanned text, readable in the full document.
- 04
Disinfecting agents and cleaning pads or wipes used in the ISO 5…
- 05
The use of sporicidal agents in the cleanrooms and/or ISO…
This inspection in context
Juanita P. Versace
9 documents · 2009–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmOne Way Drug LLC dba Partell Specialty Pharmacy history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
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 9 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected One Way Drug LLC dba Partell Specialty Pharmacy?
Juanita P. Versace and Lucila B. Nwatu are named on this Form 483, for the inspection of Feb 26 – Mar 8, 2018. 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 Feb 26 – Mar 8, 2018, and the Form 483 is dated March 8, 2018.
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.