Triangle Compounding
FDA inspection history across 3 sites, 2013 to 2019
- 5
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2013: one Form 483; 2014: one Form 483 and one warning letter; 2015: one warning letter and one Form 483; 2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–19Five Form 483s and two warning letters, at Cary, North Carolina; Cary, Georgia and Caty, North Carolina.
- 2017The longest 483 on file: 11 observations over 12 pages at Cary, North Carolina.
Cited most
Across all Triangle Compounding observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.192Production record review4
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.166Stability testing2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
The complete Triangle Compounding file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Cary, North Carolina
Three Form 483s and two warning letters · 2013 to 2017 · 24 observations
Latest: Form 483, Jul 13, 2017 →Caty, North Carolina
One Form 483 · 2019 · 1 observation
Latest: Form 483, Apr 4, 2019 →Cary, Georgia
One Form 483 · 2015 · 3 observations
Latest: Form 483, Jan 16, 2015 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-04-04 | 483 Form 483 | Caty, North Carolina | 1 | $99 |
| 2017-07-13 | 483 Form 483 | Cary, North Carolina | 11 | $99 |
| 2015-11-02 | Warning letter Warning letter | Cary, North Carolina | — | $99 |
| 2015-01-16 | 483 Form 483 | Cary, Georgia | 3 | $99 |
| 2014-09-22 | 483 Form 483 | Cary, North Carolina | 7 | $99 |
| 2014-01-14 | Warning letter Warning letter | Cary, North Carolina | — | $99 |
| 2013-03-01 | 483 Form 483 | Cary, North Carolina | 6 | $99 |
Investigators on these documents
Seneca Toms (2)Adam R. Cooke (2)Marie F. Mathews (1)Noreen Muniz (1)Rachael L. Cook (1)Tomika L. Bivens (1)Viviana Matta (1)Bonita S. Chester (1)
FEI number 3004969894 · most recent document Apr 4, 2019
About Triangle Compounding
How many FDA Form 483s has Triangle Compounding received?
FDA Intel has 5 Form 483s on file for Triangle Compounding; the most recent is dated Apr 4, 2019.
When was Triangle Compounding last inspected by FDA?
The most recent FDA inspection document on file for Triangle Compounding is a Form 483 dated Apr 4, 2019, for the site in Caty, North Carolina.
What did FDA cite at Triangle Compounding?
The regulations cited most in the observations on file for Triangle Compounding are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.42 (Design and construction features), 4 times.
Has Triangle Compounding received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Triangle Compounding; the most recent is dated Nov 2, 2015.