Triangle Compounding
Form 483 issued July 13, 2017 · Cary, North Carolina
- Inspection
- Jun 26 – Jul 13, 2017
- Investigators
- Adam R. Cooke· Rachael L. Cook· Seneca Toms
- Observations
- 11
- Pages
- 12
- FEI number
- 3004969894
In short: On July 13, 2017, FDA issued a Form 483 with 11 observations to Triangle Compounding in Cary, North Carolina (FEI 3004969894) after an inspection that ran Jun 26 – Jul 13, 2017. The investigators were Adam R. Cooke, Rachael L. Cook and Seneca Toms. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.192 (2×)
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
The responsibilities and procedures applicable to the quality control unit…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
Aseptic processing areas are deficient regarding the system for…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Triangle Compounding?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Triangle Compounding?
Adam R. Cooke, Rachael L. Cook and Seneca Toms are named on this Form 483, for the inspection of Jun 26 – Jul 13, 2017. Each investigator has a profile showing what they cite most.
When was Triangle Compounding inspected by FDA?
The inspection ran Jun 26 – Jul 13, 2017, and the Form 483 is dated July 13, 2017.
How do I get the full Form 483 for Triangle Compounding?
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