Triangle Compounding
Form 483 issued September 22, 2014 · Cary, North Carolina
- Inspection
- Sep 8 – Sep 22, 2014
- Investigator
- Tomika L. Bivens
- Observations
- 7
- Pages
- 5
- FEI number
- 3004969894
In short: On September 22, 2014, FDA issued a Form 483 with 7 observations to Triangle Compounding in Cary, North Carolina (FEI 3004969894) after an inspection that ran Sep 8 – Sep 22, 2014. The investigator was Tomika L. Bivens. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Complaint records are deficient in that they do not include the findings of…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
I! I ' establishment of scientifically sound and appropnate standards and test procedures Laboratory controls do…
This inspection in context
Tomika L. Bivens
3 documents · 2014–2020
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triangle Compounding?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Triangle Compounding?
Tomika L. Bivens is named on this Form 483, for the inspection of Sep 8 – Sep 22, 2014. Each investigator has a profile showing what they cite most.
When was Triangle Compounding inspected by FDA?
The inspection ran Sep 8 – Sep 22, 2014, and the Form 483 is dated September 22, 2014.
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.