TriRx Huntsville Pharmaceutical Services, LLC
Form 483 issued April 1, 2022 · Huntsville, Alabama
- Inspection
- Mar 22 – Apr 1, 2022
- Investigator
- Brittny C. Cargo
- Observations
- 2
- Pages
- 5
- FEI number
- 3003197096
In short: On April 1, 2022, FDA issued a Form 483 with 2 observations to TriRx Huntsville Pharmaceutical Services, LLC in Huntsville, Alabama (FEI 3003197096) after an inspection that ran Mar 22 – Apr 1, 2022. The investigator was Brittny C. Cargo. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 2 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 objectionable microorganisms in drug products not required to be…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Brittny C. Cargo
14 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Louisiana.
The firmTriRx Huntsville Pharmaceutical Services, LLC history
All 2 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 TriRx Huntsville Pharmaceutical Services, LLC?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected TriRx Huntsville Pharmaceutical Services, LLC?
Brittny C. Cargo is named on this Form 483, for the inspection of Mar 22 – Apr 1, 2022. Each investigator has a profile showing what they cite most.
When was TriRx Huntsville Pharmaceutical Services, LLC inspected by FDA?
The inspection ran Mar 22 – Apr 1, 2022, and the Form 483 is dated April 1, 2022.
How do I get the full Form 483 for TriRx Huntsville Pharmaceutical Services, LLC?
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.