Sentio BioSciences LLC
Form 483 issued February 6, 2024 · Maryland Heights, Missouri
- Inspection
- Jan 31 – Feb 6, 2024
- Investigator
- Monica E. Murie
- Observations
- 1
- Pages
- 3
- FEI number
- 3007640515
In short: On February 6, 2024, FDA issued a Form 483 with 1 observation to Sentio BioSciences LLC in Maryland Heights, Missouri (FEI 3007640515) after an inspection that ran Jan 31 – Feb 6, 2024. The investigator was Monica E. Murie. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(b) (4) used in the final isolation and purification steps during the manufacturing of non-sterile API…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Missouri.
The firmSentio BioSciences LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sentio BioSciences LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Sentio BioSciences LLC?
Monica E. Murie is named on this Form 483, for the inspection of Jan 31 – Feb 6, 2024. Each investigator has a profile showing what they cite most.
When was Sentio BioSciences LLC inspected by FDA?
The inspection ran Jan 31 – Feb 6, 2024, and the Form 483 is dated February 6, 2024.
How do I get the full Form 483 for Sentio BioSciences 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.