Medistat RX, LLC
Form 483 issued September 18, 2014 · Foley, Alabama
- Inspection
- Sep 9 – Sep 18, 2014
- Investigator
- Claire M. Minden
- Observations
- 10
- Pages
- 6
- FEI number
- 3006014626
In short: On September 18, 2014, FDA issued a Form 483 with 10 observations to Medistat RX, LLC in Foley, Alabama (FEI 3006014626) after an inspection that ran Sep 9 – Sep 18, 2014. The investigator was Claire M. Minden. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Production and laboratory controls account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding. the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Drug products failing to meet established…
- 04
Each batch of drug product purporting lobe pyrogen-free is not laboratory tested to detemline c:onfonnance…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmMedistat RX, 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 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medistat RX, LLC?
FDA listed 10 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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.
Who inspected Medistat RX, LLC?
Claire M. Minden is named on this Form 483, for the inspection of Sep 9 – Sep 18, 2014. Each investigator has a profile showing what they cite most.
When was Medistat RX, LLC inspected by FDA?
The inspection ran Sep 9 – Sep 18, 2014, and the Form 483 is dated September 18, 2014.
How do I get the full Form 483 for Medistat RX, 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.