Simtra US LLC
Form 483 issued July 26, 2024 · Bloomington, Indiana
- Investigator
- Xiuju Lu
- Observations
- 1
- Pages
- 2
- FEI number
- 1000115571
In short: On July 26, 2024, FDA issued a Form 483 with 1 observation to Simtra US LLC in Bloomington, Indiana (FEI 1000115571). The investigator was Xiuju Lu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Established procedures for manufacturing…
This inspection in context
Xiuju Lu
3 documents · 2024–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Indiana.
The firmSimtra US LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Simtra US LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Simtra US LLC?
Xiuju Lu is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Simtra US LLC inspected by FDA?
This Form 483 is dated July 26, 2024.
How do I get the full Form 483 for Simtra US 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.