Marcus Research Laboratory, Inc.
Form 483 issued September 2, 2022 · Saint Louis, Missouri
- Inspection
- Aug 22 – Sep 2, 2022
- Investigators
- Jacob G. Lutz· Michele Perry Williams· Monica E. Murie
- Observations
- 9
- Pages
- 11
- FEI number
- 1950348
In short: On September 2, 2022, FDA issued a Form 483 with 9 observations to Marcus Research Laboratory, Inc. in Saint Louis, Missouri (FEI 1950348) after an inspection that ran Aug 22 – Sep 2, 2022. The investigators were Jacob G. Lutz, Michele Perry Williams and Monica E. Murie. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 7 of 9 observations.
Most cited: 21 CFR 211.100 (2×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The overall policy, intentions, and approach to process validation designed to assure that APIs have the…
- 02
Critical equipment has not…
- 03
Buildings used in the manufacture of intermediates and APIs are not properly maintained and repaired and…
- 04
Written procedures established for cleaning equipment are not established and followed. Where established, cleaning procedures do…
This inspection in context
Jacob G. Lutz
14 documents · 2019–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmMarcus Research Laboratory, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Marcus Research Laboratory, Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Marcus Research Laboratory, Inc.?
Jacob G. Lutz, Michele Perry Williams and Monica E. Murie are named on this Form 483, for the inspection of Aug 22 – Sep 2, 2022. Each investigator has a profile showing what they cite most.
When was Marcus Research Laboratory, Inc. inspected by FDA?
The inspection ran Aug 22 – Sep 2, 2022, and the Form 483 is dated September 2, 2022.
How do I get the full Form 483 for Marcus Research Laboratory, 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.