Triangle Compounding
Form 483 issued March 1, 2013 · Cary, North Carolina
- Inspection
- Feb 19 – Mar 1, 2013
- Investigators
- Bonita S. Chester· Noreen Muniz
- Observations
- 6
- Pages
- 7
- FEI number
- 3004969894
In short: On March 1, 2013, FDA issued a Form 483 with 6 observations to Triangle Compounding in Cary, North Carolina (FEI 3004969894) after an inspection that ran Feb 19 – Mar 1, 2013. The investigators were Bonita S. Chester and Noreen Muniz. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 5 of 6 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
The control systems necessary to prevent contamination…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
This inspection in context
Bonita S. Chester
17 documents · 2013–2021
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triangle Compounding?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Triangle Compounding?
Bonita S. Chester and Noreen Muniz are named on this Form 483, for the inspection of Feb 19 – Mar 1, 2013. Each investigator has a profile showing what they cite most.
When was Triangle Compounding inspected by FDA?
The inspection ran Feb 19 – Mar 1, 2013, and the Form 483 is dated March 1, 2013.
How do I get the full Form 483 for Triangle Compounding?
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