Meridian Medical Technologies, LLC
Form 483 issued March 4, 2013 · Brentwood, Missouri
- Inspection
- Jan 24 – Mar 4, 2013
- Investigators
- Amir A. Abdalla· Kathleen B. Swat· Michele Perry Williams
- Observations
- 9
- Pages
- 9
- FEI number
- 1950222
In short: On March 4, 2013, FDA issued a Form 483 with 9 observations to Meridian Medical Technologies, LLC in Brentwood, Missouri (FEI 1950222) after an inspection that ran Jan 24 – Mar 4, 2013. The investigators were Amir A. Abdalla, Kathleen B. Swat and Michele Perry Williams. Most observations concern quality system and production.
At a glance
Quality system and production account for 6 of 9 observations.
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 whether or not the batch…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Batch production and control records do not include complete information relating to the production and…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Amir A. Abdalla
1 document · 2013
Cites 211.100 (written procedures; deviations) 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 211.192
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 quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Meridian Medical Technologies, LLC?
Amir A. Abdalla, Kathleen B. Swat and Michele Perry Williams are named on this Form 483, for the inspection of Jan 24 – Mar 4, 2013. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, LLC inspected by FDA?
The inspection ran Jan 24 – Mar 4, 2013, and the Form 483 is dated March 4, 2013.
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.