Triangle Compounding
Form 483 issued January 16, 2015 · Cary, Georgia
- Inspection
- Jan 12 – Jan 16, 2015
- Investigators
- Marie F. Mathews· Viviana Matta
- Observations
- 3
- Pages
- 2
- FEI number
- 3004969894
In short: On January 16, 2015, FDA issued a Form 483 with 3 observations to Triangle Compounding in Cary, Georgia (FEI 3004969894) after an inspection that ran Jan 12 – Jan 16, 2015. The investigators were Marie F. Mathews and Viviana Matta. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not…
- 02
There is no written testing program designed to assess the…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the…
This inspection in context
Marie F. Mathews
1 document · 2015
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Georgia.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triangle Compounding?
FDA listed 3 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Triangle Compounding?
Marie F. Mathews and Viviana Matta are named on this Form 483, for the inspection of Jan 12 – Jan 16, 2015. Each investigator has a profile showing what they cite most.
When was Triangle Compounding inspected by FDA?
The inspection ran Jan 12 – Jan 16, 2015, and the Form 483 is dated January 16, 2015.
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.