Barclay luke & Pillai Specialty Pharmacy PLLC
FDA inspection history across 2 sites, 2016 to 2024
- 3
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Warning letter
- Form 483
2016: one Form 483; 2018: one Form 483; 2022: one Form 483; 2023: one warning letter; 2024: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s, at Las Vegas, Nevada.
- 2018The longest 483 on file: 11 observations over 9 pages at Las Vegas, Nevada.
- 2022–24One Form 483, one warning letter and one close-out letter, at Las Vegas, Nevada and Nevada.
Cited most
Across all Barclay luke & Pillai Specialty Pharmacy PLLC observations on file
- FDCA 501(a)(2)(A)Insanitary conditions4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.166(a)Stability testing1
The complete Barclay luke & Pillai Specialty Pharmacy PLLC file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Las Vegas, Nevada
Three Form 483s · 2016 to 2022 · 19 observations
Latest: Form 483, Dec 9, 2022 →Nevada
One close-out letter and one warning letter · 2023 to 2024
Latest: Close-out, Mar 15, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-15 | Close-out Close-out letter | Nevada | — | $99 |
| 2023-09-14 | Warning letter Warning letter | Nevada | — | $99 |
| 2022-12-09 | 483 Form 483 | Las Vegas, Nevada | 7 | $99 |
| 2018-12-14 | 483 Form 483 | Las Vegas, Nevada | 11 | $99 |
| 2016-12-20 | 483 Form 483 | Las Vegas, Nevada | 1 | $99 |
Investigators on these documents
Ashar P. Parikh (1)Christopher R. Czajka (1)Eileen A. Liu (1)Lucila B. Nwatu (1)Uttaniti Limchumroon (1)
FEI number 3011888866 · most recent document Mar 15, 2024
About Barclay luke & Pillai Specialty Pharmacy PLLC
How many FDA Form 483s has Barclay luke & Pillai Specialty Pharmacy PLLC received?
FDA Intel has 3 Form 483s on file for Barclay luke & Pillai Specialty Pharmacy PLLC; the most recent is dated Dec 9, 2022.
When was Barclay luke & Pillai Specialty Pharmacy PLLC last inspected by FDA?
The most recent FDA inspection document on file for Barclay luke & Pillai Specialty Pharmacy PLLC is a Form 483 dated Dec 9, 2022, for the site in Las Vegas, Nevada.
What did FDA cite at Barclay luke & Pillai Specialty Pharmacy PLLC?
The regulations cited most in the observations on file for Barclay luke & Pillai Specialty Pharmacy PLLC are FDCA 501(a)(2)(A) (Insanitary conditions), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 3 times.
Has Barclay luke & Pillai Specialty Pharmacy PLLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Barclay luke & Pillai Specialty Pharmacy PLLC; the most recent is dated Sep 14, 2023.