Stonegate Pharmacy LP
FDA inspection history across 2 sites, 2016 to 2020
- 4
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2016: two Form 483s and one warning letter; 2019: one Form 483 and one close-out letter; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016Two Form 483s and one warning letter, at Austin, Texas and Aus t i n, Texas.
- 2016The longest 483 on file: 12 observations over 9 pages at Austin, Texas.
- 2019–20Two Form 483s and one close-out letter, at Austin, Texas.
Cited most
Across all Stonegate Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.42(c)(10)(iv)Design and construction features4
- 21 CFR 211.94(b)Drug product containers and closures4
- FDCA 501(a)(2)(A)Insanitary conditions4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
The complete Stonegate Pharmacy file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Austin, Texas
Three Form 483s, one close-out letter and one warning letter · 2016 to 2020 · 21 observations
Latest: Form 483, Jun 11, 2020 →Aus t i n, Texas
One Form 483 · 2016 · 12 observations
Latest: Form 483, Mar 2, 2016 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-06-11 | 483 Form 483 | Austin, Texas | 4 | $99 |
| 2019-08-09 | 483 Form 483 | Austin, Texas | 5 | $99 |
| 2019-04-24 | Close-out Close-out letter | Austin, Texas | — | $99 |
| 2016-11-10 | Warning letter Warning letter | Austin, Texas | — | $99 |
| 2016-03-23 | 483 Form 483 | Austin, Texas | 12 | $99 |
| 2016-03-02 | 483 Form 483 | Aus t i n, Texas | 12 | $99 |
Investigators on these documents
Patty P. Kaewussdangkul (3)Jason R. Caballero (1)Margaret M. Annes (1)
FEI number 3012038236 · most recent document Jun 11, 2020
About Stonegate Pharmacy LP
How many FDA Form 483s has Stonegate Pharmacy LP received?
FDA Intel has 4 Form 483s on file for Stonegate Pharmacy LP; the most recent is dated Jun 11, 2020.
When was Stonegate Pharmacy LP last inspected by FDA?
The most recent FDA inspection document on file for Stonegate Pharmacy LP is a Form 483 dated Jun 11, 2020, for the site in Austin, Texas.
What did FDA cite at Stonegate Pharmacy LP?
The regulations cited most in the observations on file for Stonegate Pharmacy LP are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.42(c)(10)(iv) (Design and construction features), 4 times; 21 CFR 211.94(b) (Drug product containers and closures), 4 times.
Has Stonegate Pharmacy LP received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Stonegate Pharmacy LP; the most recent is dated Nov 10, 2016.