BRS Analytical Services LLC
Form 483 issued March 26, 2025 · Saint Louis, Missouri
- Inspection
- Mar 10 – Mar 26, 2025
- Investigators
- Eric D. Bowles· Matthew Schuckmann
- Observations
- 5
- Pages
- 16
- FEI number
- 3023604380
In short: On March 26, 2025, FDA issued a Form 483 with 5 observations to BRS Analytical Services LLC in Saint Louis, Missouri (FEI 3023604380) after an inspection that ran Mar 10 – Mar 26, 2025. The investigators were Eric D. Bowles and Matthew Schuckmann. Most observations concern facilities & equipment and production.
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
Your firm failed to…
- 02
Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological…
- 03
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling…
- 04
Your firm failed to establish an adequate quality control unit with the responsibility and authority to…
This inspection in context
Eric D. Bowles
5 documents · 2024–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmBRS Analytical Services LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BRS Analytical Services LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected BRS Analytical Services LLC?
Eric D. Bowles and Matthew Schuckmann are named on this Form 483, for the inspection of Mar 10 – Mar 26, 2025. Each investigator has a profile showing what they cite most.
When was BRS Analytical Services LLC inspected by FDA?
The inspection ran Mar 10 – Mar 26, 2025, and the Form 483 is dated March 26, 2025.
How do I get the full Form 483 for BRS Analytical Services LLC?
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.