Meridian Medical Technologies, LLC
Form 483 issued June 5, 2024 · St. Louis, Missouri
- Inspection
- May 20 – Jun 5, 2024
- Investigators
- Jacob G. Lutz· Joohi Castelvetere· Karen M. Cruz Arenas
- Observations
- 9
- Pages
- 18
- FEI number
- 1950222
In short: On June 5, 2024, FDA issued a Form 483 with 9 observations to Meridian Medical Technologies, LLC in St. Louis, Missouri (FEI 1950222) after an inspection that ran May 20 – Jun 5, 2024. The investigators were Jacob G. Lutz, Joohi Castelvetere, Karen M. Cruz Arenas, Monica C. Burgos Garcia and Robert J. Ham. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Jacob G. Lutz
14 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmMeridian Medical Technologies, LLC history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meridian Medical Technologies, LLC?
FDA listed 9 observations on this Form 483, mostly about production, laboratory controls and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Meridian Medical Technologies, LLC?
Jacob G. Lutz, Joohi Castelvetere, Karen M. Cruz Arenas, Monica C. Burgos Garcia and Robert J. Ham are named on this Form 483, for the inspection of May 20 – Jun 5, 2024. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, LLC inspected by FDA?
The inspection ran May 20 – Jun 5, 2024, and the Form 483 is dated June 5, 2024.
How do I get the full Form 483 for Meridian Medical Technologies, 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.