Meridian Medical Technologies, Inc.
Form 483 issued October 9, 2013 · Saint Louis, Kansas
- Inspection
- Sep 25 – Oct 9, 2013
- Investigators
- Kimberly E. Pera· Paul G. Klepper· Sherry L. Bouse
- Observations
- 7
- Pages
- 6
- FEI number
- 1937280
In short: On October 9, 2013, FDA issued a Form 483 with 7 observations to Meridian Medical Technologies, Inc. in Saint Louis, Kansas (FEI 1937280) after an inspection that ran Sep 25 – Oct 9, 2013. The investigators were Kimberly E. Pera, Paul G. Klepper and Sherry L. Bouse. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.192 (3×) · 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
The quality control unit lacks authority to review production records to assure that no errors have…
- 04
Written production and process control procedures are not followed in the execution ofproduction…
This inspection in context
Kimberly E. Pera
1 document · 2013
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
The firmMeridian Medical Technologies, Inc. history
All 2 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, Inc.?
FDA listed 7 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Meridian Medical Technologies, Inc.?
Kimberly E. Pera, Paul G. Klepper and Sherry L. Bouse are named on this Form 483, for the inspection of Sep 25 – Oct 9, 2013. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, Inc. inspected by FDA?
The inspection ran Sep 25 – Oct 9, 2013, and the Form 483 is dated October 9, 2013.
How do I get the full Form 483 for Meridian Medical Technologies, Inc.?
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.