Triangle Compounding
Form 483 issued April 4, 2019 · Caty, North Carolina
- Inspection
- Mar 26 – Apr 4, 2019
- Investigators
- Adam R. Cooke· Seneca Toms
- Observations
- 1
- Pages
- 2
- FEI number
- 3004969894
In short: On April 4, 2019, FDA issued a Form 483 with 1 observation to Triangle Compounding in Caty, North Carolina (FEI 3004969894) after an inspection that ran Mar 26 – Apr 4, 2019. The investigators were Adam R. Cooke and Seneca Toms. Most observations concern materials; the most-cited regulation is 21 CFR 211.94 (drug product containers and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.94 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product has been prepared using a method of manufacture that does not assure it meets…
This inspection in context
Adam R. Cooke
11 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in North Carolina.
The firmTriangle Compounding history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.94
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triangle Compounding?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.94 (drug product containers and closures). The opening words of each observation are shown on this page.
Who inspected Triangle Compounding?
Adam R. Cooke and Seneca Toms are named on this Form 483, for the inspection of Mar 26 – Apr 4, 2019. Each investigator has a profile showing what they cite most.
When was Triangle Compounding inspected by FDA?
The inspection ran Mar 26 – Apr 4, 2019, and the Form 483 is dated April 4, 2019.
How do I get the full Form 483 for Triangle Compounding?
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.