Marcus Research Laboratory, Inc.
FDA inspection history across 2 sites, 2019 to 2024
- 4
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2019: one Form 483; 2021: one warning letter and one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–24Four Form 483s and one warning letter, at Saint Louis, Missouri.
- 2022The longest 483 on file: 9 observations over 11 pages at Saint Louis, Missouri.
Cited most
Across all Marcus Research Laboratory observations on file
- 21 CFR 211.67Equipment cleaning and maintenance5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.192Production record review3
- 21 CFR 211.130Packaging and labeling operations2
- 21 CFR 211.166Stability testing2
The complete Marcus Research Laboratory file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Saint Louis, Missouri
Four Form 483s and one warning letter · 2019 to 2024 · 26 observations
Latest: Form 483, Jul 12, 2024 →St. Louis, Missouri
One close-out letter
Latest: Close-out, — →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-12 | 483 Form 483 | Saint Louis, Missouri | 3 | $99 |
| 2022-09-02 | 483 Form 483 | Saint Louis, Missouri | 9 | $99 |
| 2021-09-30 | Warning letter Warning letter | Saint Louis, Missouri | — | $99 |
| 2021-05-14 | 483 Form 483 | Saint Louis, Missouri | 7 | $99 |
| 2019-12-06 | 483 Form 483 | Saint Louis, Missouri | 7 | $99 |
| Undated | Close-out Close-out letter | St. Louis, Missouri | — | $99 |
Investigators on these documents
Jacob G. Lutz (1)Matthew Schuckmann (1)Michele Perry Williams (1)Monica E. Murie (1)Wayne D. McGrath (1)
FEI number 1950348 · most recent document Jul 12, 2024
About Marcus Research Laboratory, Inc.
How many FDA Form 483s has Marcus Research Laboratory, Inc. received?
FDA Intel has 4 Form 483s on file for Marcus Research Laboratory, Inc.; the most recent is dated Jul 12, 2024.
When was Marcus Research Laboratory, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Marcus Research Laboratory, Inc. is a Form 483 dated Jul 12, 2024, for the site in Saint Louis, Missouri.
What did FDA cite at Marcus Research Laboratory, Inc.?
The regulations cited most in the observations on file for Marcus Research Laboratory, Inc. are 21 CFR 211.67 (Equipment cleaning and maintenance), 5 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.192 (Production record review), 3 times.
Has Marcus Research Laboratory, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Marcus Research Laboratory, Inc.; the most recent is dated Sep 30, 2021.