Meridian Medical Technologies, LLC
Form 483 issued February 21, 2014 · St. Louis, Missouri
- Inspection
- Jan 27 – Feb 21, 2014
- Investigators
- James D. Planchon· Michele Perry Williams· Thomas J. Arista
- Observations
- 20
- Pages
- 16
- FEI number
- 1950222
In short: On February 21, 2014, FDA issued a Form 483 with 20 observations to Meridian Medical Technologies, LLC in St. Louis, Missouri (FEI 1950222) after an inspection that ran Jan 27 – Feb 21, 2014. The investigators were James D. Planchon, Michele Perry Williams and Thomas J. Arista. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
6 of 9 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The “Media Challenge Of Aseptic Processes” document number SOP-QLA-VAL-0020 version 8.0 effective date 18 SEP 2013…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The “Media Challenge Of Aseptic Processes" document number SOP-QLA-VAL-00020, version 8.0, effective date 18 SEP 2013…
- 04
The “Performing Contamination Check On Media Fills” document number SOP-LAB-ENV-00607, dated 23 JUL 2013 establishes “a…
This inspection in context
James D. Planchon
1 document · 2014
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meridian Medical Technologies, LLC?
FDA listed 20 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Meridian Medical Technologies, LLC?
James D. Planchon, Michele Perry Williams and Thomas J. Arista are named on this Form 483, for the inspection of Jan 27 – Feb 21, 2014. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, LLC inspected by FDA?
The inspection ran Jan 27 – Feb 21, 2014, and the Form 483 is dated February 21, 2014.
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.