Barclay luke & Pillai Specialty Pharmacy PLLC
Form 483 issued December 14, 2018 · Las Vegas, Nevada
- Inspection
- Nov 27 – Dec 14, 2018
- Investigator
- Uttaniti Limchumroon
- Observations
- 11
- Pages
- 9
- FEI number
- 3011888866
In short: On December 14, 2018, FDA issued a Form 483 with 11 observations to Barclay luke & Pillai Specialty Pharmacy PLLC in Las Vegas, Nevada (FEI 3011888866) after an inspection that ran Nov 27 – Dec 14, 2018. The investigator was Uttaniti Limchumroon. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
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 diug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system for…
- 03FDCA 501(a)(2)(A)
You did not have a HEP A filter over the area to which…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) 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(b)
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 11 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Barclay luke & Pillai Specialty Pharmacy PLLC?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Nov 27 – Dec 14, 2018. Each investigator has a profile showing what they cite most.
When was Barclay luke & Pillai Specialty Pharmacy PLLC inspected by FDA?
The inspection ran Nov 27 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
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.