Sentio BioSciences LLC
Form 483 issued April 19, 2019 · Maryland Heights, Missouri
- Inspection
- Apr 10 – Apr 19, 2019
- Investigator
- Tiara N. Brown-Crosen
- Observations
- 3
- Pages
- 3
- FEI number
- 3007640515
In short: On April 19, 2019, FDA issued a Form 483 with 3 observations to Sentio BioSciences LLC in Maryland Heights, Missouri (FEI 3007640515) after an inspection that ran Apr 10 – Apr 19, 2019. The investigator was Tiara N. Brown-Crosen. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
3 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×) · 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures for the qualification of equipment fail to include specific details of the…
- 02
Written procedures approved by the quality unit are not follow and do not always include sufficient…
- 03
Failure to include label specimens…
This inspection in context
Tiara N. Brown-Crosen
7 documents · 2016–2019
Cites 211.166 (stability testing) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sentio BioSciences LLC?
FDA listed 3 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Sentio BioSciences LLC?
Tiara N. Brown-Crosen is named on this Form 483, for the inspection of Apr 10 – Apr 19, 2019. Each investigator has a profile showing what they cite most.
When was Sentio BioSciences LLC inspected by FDA?
The inspection ran Apr 10 – Apr 19, 2019, and the Form 483 is dated April 19, 2019.
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.