Barclay luke & Pillai Specialty Pharmacy PLLC
Form 483 issued December 20, 2016 · Las Vegas, Nevada
- Inspection
- Dec 12 – Dec 20, 2016
- Investigators
- Ashar P. Parikh· Eileen A. Liu· Lucila B. Nwatu
- Observations
- 1
- Pages
- 12
- FEI number
- 3011888866
In short: On December 20, 2016, FDA issued a Form 483 with 1 observation to Barclay luke & Pillai Specialty Pharmacy PLLC in Las Vegas, Nevada (FEI 3011888866) after an inspection that ran Dec 12 – Dec 20, 2016. The investigators were Ashar P. Parikh, Eileen A. Liu and Lucila B. Nwatu. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
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 firmBarclay luke & Pillai Specialty Pharmacy PLLC history
All 5 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 Barclay luke & Pillai Specialty Pharmacy PLLC?
FDA listed 1 observation on this Form 483, mostly about production. 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 Barclay luke & Pillai Specialty Pharmacy PLLC?
Ashar P. Parikh, Eileen A. Liu and Lucila B. Nwatu are named on this Form 483, for the inspection of Dec 12 – Dec 20, 2016. Each investigator has a profile showing what they cite most.
When was Barclay luke & Pillai Specialty Pharmacy PLLC inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2016, and the Form 483 is dated December 20, 2016.
How do I get the full Form 483 for Barclay luke & Pillai Specialty Pharmacy PLLC?
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.