Barclay luke & Pillai Specialty Pharmacy PLLC
Form 483 issued December 9, 2022 · Las Vegas, Nevada
- Inspection
- Nov 28 – Dec 9, 2022
- Investigator
- Christopher R. Czajka
- Observations
- 7
- Pages
- 8
- FEI number
- 3011888866
In short: On December 9, 2022, FDA issued a Form 483 with 7 observations to Barclay luke & Pillai Specialty Pharmacy PLLC in Las Vegas, Nevada (FEI 3011888866) after an inspection that ran Nov 28 – Dec 9, 2022. The investigator was Christopher R. Czajka. Most observations concern facilities & equipment and laboratory controls.
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: FDCA 501(a)(2)(A) (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01FDCA 501(a)(2)(A)
The ISO 5 classified aseptic processing areas had difficult to clean and visibly…
- 02FDCA 501(a)(2)(A)
Non-microbial contamination was observed…
- 03
You produced hazardous diugs without providing adequate…
- 04FDCA 501(a)(2)(A)
Unsealed, loose ceiling tiles were…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) 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 211.42
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 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The opening words of each observation are shown on this page.
Who inspected Barclay luke & Pillai Specialty Pharmacy PLLC?
Christopher R. Czajka is named on this Form 483, for the inspection of Nov 28 – Dec 9, 2022. 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 28 – Dec 9, 2022, and the Form 483 is dated December 9, 2022.
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.