Medistat RX, LLC
Form 483 issued September 23, 2015 · Foley, Alabama
- Inspection
- Aug 24 – Sep 23, 2015
- Investigators
- Jason D. Abel· Samantha J. Bradley
- Observations
- 11
- Pages
- 8
- FEI number
- 3006014626
In short: On September 23, 2015, FDA issued a Form 483 with 11 observations to Medistat RX, LLC in Foley, Alabama (FEI 3006014626) after an inspection that ran Aug 24 – Sep 23, 2015. The investigators were Jason D. Abel and Samantha J. Bradley. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 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 are not established…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
This inspection in context
Jason D. Abel
1 document · 2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
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
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medistat RX, LLC?
FDA listed 11 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Medistat RX, LLC?
Jason D. Abel and Samantha J. Bradley are named on this Form 483, for the inspection of Aug 24 – Sep 23, 2015. Each investigator has a profile showing what they cite most.
When was Medistat RX, LLC inspected by FDA?
The inspection ran Aug 24 – Sep 23, 2015, and the Form 483 is dated September 23, 2015.
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.