Meridian Medical Technologies, LLC
Form 483 issued December 21, 2019 · St. Louis, Missouri
- Inspection
- Dec 9 – Dec 21, 2019
- Investigators
- Eric M. Padgett· Joseph R. Strelnik· Matthew Ondeck
- Observations
- 11
- Pages
- 20
- FEI number
- 1950222
In short: On December 21, 2019, FDA issued a Form 483 with 11 observations to Meridian Medical Technologies, LLC in St. Louis, Missouri (FEI 1950222) after an inspection that ran Dec 9 – Dec 21, 2019. The investigators were Eric M. Padgett, Joseph R. Strelnik, Matthew Ondeck and Robert J. Ham. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and capa account for 7 of 11 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Design verification does not confirm that design output…
- 03
Procedures for design validation have…
- 04
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
This inspection in context
Eric M. Padgett
1 document · 2019
Cites 820.30(f) (design controls) more than any other section. Most of their documents are for sites in Missouri.
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 820.100(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 11 observations on this Form 483, mostly about production & process controls, cAPA 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?
Eric M. Padgett, Joseph R. Strelnik, Matthew Ondeck and Robert J. Ham are named on this Form 483, for the inspection of Dec 9 – Dec 21, 2019. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, LLC inspected by FDA?
The inspection ran Dec 9 – Dec 21, 2019, and the Form 483 is dated December 21, 2019.
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.