Marcus Research Laboratory, Inc.
Form 483 issued December 6, 2019 · Saint Louis, Missouri
- Inspection
- Dec 6, 2019
- Observations
- 7
- Pages
- 6
- FEI number
- 1950348
In short: On December 6, 2019, FDA issued a Form 483 with 7 observations to Marcus Research Laboratory, Inc. in Saint Louis, Missouri (FEI 1950348) after an inspection that ran Dec 6, 2019. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not fully followed…
- 02
Written procedures are not established for production and process control designed to assure that your drug…
- 03
The written stability program for drug products do not include reliable, meaningful…
- 04
Packaged and labeled intermediates or APIs should be examined to ensure that containers and packages in…
This inspection in context
Questions about this 483
What did FDA find at Marcus Research Laboratory, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Marcus Research Laboratory, Inc. inspected by FDA?
The inspection ran Dec 6, 2019, and the Form 483 is dated December 6, 2019.
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.