Sentio BioSciences LLC
FDA inspection history in Maryland Heights, Missouri, 2017 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19Two Form 483s, at Maryland Heights, Missouri.
- 2017The longest 483 on file: 7 observations over 8 pages at Maryland Heights, Missouri.
- 2024One Form 483, at Maryland Heights, Missouri.
Cited most
Across all Sentio BioSciences observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.180General requirements1
The complete Sentio BioSciences file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Maryland Heights, Missouri
Three Form 483s · 2017 to 2024 · 11 observations
Latest: Form 483, Feb 6, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-02-06 | 483 Form 483 | Maryland Heights, Missouri | 1 | $99 |
| 2019-04-19 | 483 Form 483 | Maryland Heights, Missouri | 3 | $99 |
| 2017-05-19 | 483 Form 483 | Maryland Heights, Missouri | 7 | $99 |
Investigators on these documents
Kellia N. Hicks (1)Monica E. Murie (1)Tiara N. Brown-Crosen (1)
FEI number 3007640515 · most recent document Feb 6, 2024
About Sentio BioSciences LLC
How many FDA Form 483s has Sentio BioSciences LLC received?
FDA Intel has 3 Form 483s on file for Sentio BioSciences LLC; the most recent is dated Feb 6, 2024.
When was Sentio BioSciences LLC last inspected by FDA?
The most recent FDA inspection document on file for Sentio BioSciences LLC is a Form 483 dated Feb 6, 2024, for the site in Maryland Heights, Missouri.
What did FDA cite at Sentio BioSciences LLC?
The regulations cited most in the observations on file for Sentio BioSciences LLC are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.113 (Control of microbiological contamination), 1 time.