Sentio BioSciences LLC
Form 483 issued May 19, 2017 · Maryland Heights, Missouri
- Inspection
- Apr 24 – May 19, 2017
- Investigator
- Kellia N. Hicks
- Observations
- 7
- Pages
- 8
- FEI number
- 3007640515
In short: On May 19, 2017, FDA issued a Form 483 with 7 observations to Sentio BioSciences LLC in Maryland Heights, Missouri (FEI 3007640515) after an inspection that ran Apr 24 – May 19, 2017. The investigator was Kellia N. Hicks. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control procedures are not established or followed which monitor the output and validate the performance of…
- 02
Equipment cleaning and maintenance procedures are not established or…
- 03
Procedures describing the handling of all written and oral complaints regarding a drug…
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sentio BioSciences LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Sentio BioSciences LLC?
Kellia N. Hicks is named on this Form 483, for the inspection of Apr 24 – May 19, 2017. Each investigator has a profile showing what they cite most.
When was Sentio BioSciences LLC inspected by FDA?
The inspection ran Apr 24 – May 19, 2017, and the Form 483 is dated May 19, 2017.
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.