Marcus Research Laboratory, Inc.
Form 483 issued May 14, 2021 · Saint Louis, Missouri
- Inspection
- May 3 – May 14, 2021
- Investigators
- Matthew Schuckmann· Wayne D. McGrath
- Observations
- 7
- Pages
- 5
- FEI number
- 1950348
In short: On May 14, 2021, FDA issued a Form 483 with 7 observations to Marcus Research Laboratory, Inc. in Saint Louis, Missouri (FEI 1950348) after an inspection that ran May 3 – May 14, 2021. The investigators were Matthew Schuckmann and Wayne D. McGrath. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 6 of 7 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
There should be a quality unit(s) that is independent of production and that fulfills both quality…
- 03
Equipment should be constructed so that surfaces that contact raw materials, intermediates, or APIs do not…
- 04
The responsibility for production activities should be described in writing, and should include but not necessarily…
This inspection in context
Matthew Schuckmann
7 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Marcus Research Laboratory, Inc.?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and packaging & labeling. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Marcus Research Laboratory, Inc.?
Matthew Schuckmann and Wayne D. McGrath are named on this Form 483, for the inspection of May 3 – May 14, 2021. Each investigator has a profile showing what they cite most.
When was Marcus Research Laboratory, Inc. inspected by FDA?
The inspection ran May 3 – May 14, 2021, and the Form 483 is dated May 14, 2021.
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.