Meridian Medical Technologies, LLC
Form 483 issued March 24, 2017 · Brentwood, Missouri
- Inspection
- Feb 20 – Mar 24, 2017
- Investigators
- Frank Wackes· John C. McMichael· Kellia N. Hicks
- Observations
- 14
- Pages
- 19
- FEI number
- 1950222
In short: On March 24, 2017, FDA issued a Form 483 with 14 observations to Meridian Medical Technologies, LLC in Brentwood, Missouri (FEI 1950222) after an inspection that ran Feb 20 – Mar 24, 2017. The investigators were Frank Wackes, John C. McMichael, Kellia N. Hicks, Michele L. Obert, Phillip M. Pontikos, Rick L. Friedman and Zedong Dong. Most observations concern quality system and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Quality system and design controls account for 9 of 14 observations.
Most cited: 21 CFR 820.30 (4×)
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
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug product are not…
- 04
Procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process…
This inspection in context
Frank Wackes
2 documents · 2015–2017
Cites 820.30 (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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meridian Medical Technologies, LLC?
FDA listed 14 observations on this Form 483, mostly about quality system, design controls and production. 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?
Frank Wackes, John C. McMichael, Kellia N. Hicks, Michele L. Obert, Phillip M. Pontikos, Rick L. Friedman and Zedong Dong are named on this Form 483, for the inspection of Feb 20 – Mar 24, 2017. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, LLC inspected by FDA?
The inspection ran Feb 20 – Mar 24, 2017, and the Form 483 is dated March 24, 2017.
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.