Meridian Medical Technologies, Inc.
Form 483 issued April 29, 2013 · Saint Louis, Missouri
- Inspection
- Mar 20 – Apr 29, 2013
- Investigators
- Anthony R. Bucks· Perry Williams
- Observations
- 10
- Pages
- 9
- FEI number
- 1937280
In short: On April 29, 2013, FDA issued a Form 483 with 10 observations to Meridian Medical Technologies, Inc. in Saint Louis, Missouri (FEI 1937280) after an inspection that ran Mar 20 – Apr 29, 2013. The investigators were Anthony R. Bucks and Perry Williams. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and quality system account for 7 of 10 observations.
Most cited: 21 CFR 211.165 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks authority to review production records to assure that no errors have…
- 02
Employees engaged in the manufacture, processing, packing, and holding of a drug product lack the training…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Drug products failing to meet established…
This inspection in context
Anthony R. Bucks
4 documents · 2013
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in Missouri.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Meridian Medical Technologies, Inc.?
FDA listed 10 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Meridian Medical Technologies, Inc.?
Anthony R. Bucks and Perry Williams are named on this Form 483, for the inspection of Mar 20 – Apr 29, 2013. Each investigator has a profile showing what they cite most.
When was Meridian Medical Technologies, Inc. inspected by FDA?
The inspection ran Mar 20 – Apr 29, 2013, and the Form 483 is dated April 29, 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.