Marcus Research Laboratory, Inc.
Form 483 issued July 12, 2024 · Saint Louis, Missouri
- Observations
- 3
- Pages
- 3
- FEI number
- 1950348
In short: On July 12, 2024, FDA issued a Form 483 with 3 observations to Marcus Research Laboratory, Inc. in Saint Louis, Missouri (FEI 1950348). Most observations concern facilities & equipment.
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment is not constructed so that surfaces that contact raw materials, intermediates, or APIs do not…
- 02
Equipment used in the manufacture of intermediates and APIs is not of appropriate design and adequate…
- 03
Written procedures and associated documents governing cleaning validation are not…
This inspection in context
Questions about this 483
What did FDA find at Marcus Research Laboratory, Inc.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The opening words of each observation are shown on this page.
When was Marcus Research Laboratory, Inc. inspected by FDA?
This Form 483 is dated July 12, 2024.
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.