Meridian Medical Technologies, LLC
Form 483 issued June 13, 2008 · St. Louis, Missouri
- Inspection
- Jun 2 – Jun 13, 2008
- Investigators
- Kara L. Roden· Shirley J. B. Pene
- Observations
- 4
- Pages
- 4
- FEI number
- 1950222
In short: On June 13, 2008, FDA issued a Form 483 with 4 observations to Meridian Medical Technologies, LLC in St. Louis, Missouri (FEI 1950222) after an inspection that ran Jun 2 – Jun 13, 2008. The investigators were Kara L. Roden and Shirley J. B. Pene. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 02
Buildings used in the manufacturing of a drug product are not maintained in a…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
Procedures describing the handling of all written and oral complaints regarding a drug…
This inspection in context
Kara L. Roden
2 documents · 2008–2009
Cites 211.192 (production record review) 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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meridian Medical Technologies, LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Meridian Medical Technologies, LLC?
Kara L. Roden and Shirley J. B. Pene are named on this Form 483, for the inspection of Jun 2 – Jun 13, 2008. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, LLC inspected by FDA?
The inspection ran Jun 2 – Jun 13, 2008, and the Form 483 is dated June 13, 2008.
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.