Meridian Medical Technologies, LLC
FDA inspection history across 3 sites, 2008 to 2024
- 7
- Form 483s
- 1
- Warning letter
- 1
- EIR
- 1
- Response
Every document, by year
- Form 483
- Warning letter
- EIR
- Response
2008: one Form 483; 2012: one inspection report, one 483 response and one Form 483; 2013: one Form 483; 2014: one Form 483; 2017: one warning letter and one Form 483; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2008One Form 483, at St. Louis, Missouri.
- 2012–14Three Form 483s, one inspection report and one 483 response, at Brentwood, Missouri and St. Louis, Missouri.
- 2014The longest 483 on file: 20 observations over 16 pages at St. Louis, Missouri.
- 2017–19Two Form 483s and one warning letter, at Columbia, Maryland; Brentwood, Missouri and St. Louis, Missouri.
- 2024One Form 483, at St. Louis, Missouri.
Cited most
Across all Meridian Medical Technologies observations on file
- 21 CFR 211.113Control of microbiological contamination10
- 21 CFR 820.30Design controls9
- 21 CFR 211.160General requirements4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.192Production record review3
The complete Meridian Medical Technologies file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
25% off buying them one by one
Sites
St. Louis, Missouri
Four Form 483s and one 483 response · 2008 to 2024 · 44 observations
Latest: Form 483, Jun 5, 2024 →Brentwood, Missouri
Three Form 483s and one inspection report · 2012 to 2017 · 27 observations
Latest: Form 483, Mar 24, 2017 →Columbia, Maryland
One warning letter · 2017
Latest: Warning letter, Sep 5, 2017 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-06-05 | 483 Form 483 | St. Louis, Missouri | 9 | $99 |
| 2019-12-21 | 483 Form 483 | St. Louis, Missouri | 11 | $99 |
| 2017-09-05 | Warning letter Warning letter | Columbia, Maryland | — | $99 |
| 2017-03-24 | 483 Form 483 | Brentwood, Missouri | 14 | $99 |
| 2014-02-21 | 483 Form 483 | St. Louis, Missouri | 20 | $99 |
| 2013-03-04 | 483 Form 483 | Brentwood, Missouri | 9 | $99 |
| 2012-02-13 | EIR EIR | Brentwood, Missouri | — | $550 |
| 2012-02-13 | Response 483 response | St. Louis, Missouri | — | $199 |
| 2012-02-13 | 483 Form 483 | Brentwood, Missouri | 4 | $99 |
| 2008-06-13 | 483 Form 483 | St. Louis, Missouri | 4 | $99 |
Investigators on these documents
Robert J. Ham (2)Sandra A. Hughes (2)Justin A. Boyd (2)Shirley J. Berryman (2)Matthew H. Hunt (2)Michele Perry Williams (2)Joohi Castelvetere (1)Joseph R. Strelnik (1)Kara L. Roden (1)Karen M. Cruz Arenas (1)Kathleen B. Swat (1)Kellia N. Hicks (1)
FEI number 1950222 · most recent document Jun 5, 2024
About Meridian Medical Technologies, LLC
How many FDA Form 483s has Meridian Medical Technologies, LLC received?
FDA Intel has 7 Form 483s on file for Meridian Medical Technologies, LLC; the most recent is dated Jun 5, 2024.
When was Meridian Medical Technologies, LLC last inspected by FDA?
The most recent FDA inspection document on file for Meridian Medical Technologies, LLC is a Form 483 dated Jun 5, 2024, for the site in St. Louis, Missouri.
What did FDA cite at Meridian Medical Technologies, LLC?
The regulations cited most in the observations on file for Meridian Medical Technologies, LLC are 21 CFR 211.113 (Control of microbiological contamination), 10 times; 21 CFR 820.30 (Design controls), 9 times; 21 CFR 211.160 (General requirements), 4 times.
Has Meridian Medical Technologies, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Meridian Medical Technologies, LLC; the most recent is dated Sep 5, 2017.