TriRx Huntsville Pharmaceutical Services, LLC
Form 483 issued December 19, 2014 · Huntsville, Alabama
- Observations
- 1
- Pages
- 1
- FEI number
- 3003197096
In short: On December 19, 2014, FDA issued a Form 483 with 1 observation to TriRx Huntsville Pharmaceutical Services, LLC in Huntsville, Alabama (FEI 3003197096). Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established standards, specifications, and quality control…
This inspection in context
Questions about this 483
What did FDA find at TriRx Huntsville Pharmaceutical Services, LLC?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
When was TriRx Huntsville Pharmaceutical Services, LLC inspected by FDA?
This Form 483 is dated December 19, 2014.
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.