Meridian Medical Technologies, LLC

Form 483 issued February 13, 2012 · Brentwood, Missouri

Inspection: Feb 1 – Feb 13, 2012
Investigators: Justin A. Boyd· Matthew H. Hunt· Sandra A. Hughes
Observations: 4
Pages: 4
FEI number: 1950222

In short: On February 13, 2012, FDA issued a Form 483 with 4 observations to Meridian Medical Technologies, LLC in Brentwood, Missouri (FEI 1950222) after an inspection that ran Feb 1 – Feb 13, 2012. The investigators were Justin A. Boyd, Matthew H. Hunt, Sandra A. Hughes and Shirley J. Berryman. Most observations concern production and laboratory controls.

At a glance

Production and laboratory controls account for 3 of 4 observations.

Production2

Laboratory controls1

Materials1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 211.100(b)
Observation 1: scanned text, readable in the full document.
02
21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
03
21 CFR 211.160(a)
Established laboratory control mechanisms…
04
21 CFR 211.80(a)
Written procedures are not followed for…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

Justin A. Boyd

61 documents · 2010–2026

Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.

The firm

Meridian Medical Technologies, LLC history

All 10 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.100(b)

See how FDA wrote the same problem up elsewhere.

Original PDF$99

✓ All 4 pages, as issued to the firm
✓ Searchable text
✓ Download right after checkout, yours to keep

I agree to the Terms of Service, the licence (internal use by my organization only, no sharing or resale) and the Refund Policy, and I ask for immediate access to the download, so I lose any right to cancel once it's available.

Get it free · first document

Secure checkout · receipt for expenses

Already bought it? Find an order

Licensed for use within your organization. No sharing or resale.

Complete the picture

Meridian Medical Technologies, LLC site file

All 10 documents for this site in one go: $1,156 instead of ~~$1,541~~, 25% off.

See the site history

Questions about this 483

What did FDA find at Meridian Medical Technologies, LLC?

FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and materials. The opening words of each observation are shown on this page.

Who inspected Meridian Medical Technologies, LLC?

Justin A. Boyd, Matthew H. Hunt, Sandra A. Hughes and Shirley J. Berryman are named on this Form 483, for the inspection of Feb 1 – Feb 13, 2012. Each investigator has a profile showing what they cite most.

When was Meridian Medical Technologies, LLC inspected by FDA?

The inspection ran Feb 1 – Feb 13, 2012, and the Form 483 is dated February 13, 2012.

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.