Simtra US LLC
Form 483 issued February 20, 2024 · Bloomington, Indiana
- Inspection
- Feb 14 – Feb 20, 2024
- Investigators
- Laurimer Kuilan-Torres· Ruo H. Xu· Yiwei Li
- Observations
- 7
- Pages
- 9
- FEI number
- 1000115571
In short: On February 20, 2024, FDA issued a Form 483 with 7 observations to Simtra US LLC in Bloomington, Indiana (FEI 1000115571) after an inspection that ran Feb 14 – Feb 20, 2024. The investigators were Laurimer Kuilan-Torres, Ruo H. Xu and Yiwei Li. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Aseptic processing areas are inadequate regarding the system…
- 03
Qualification of visual inspection procedures designed to assure batches of injectable drug products meet…
- 04
Quality control unit procedures and responsibilities are not…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Simtra US LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Simtra US LLC?
Laurimer Kuilan-Torres, Ruo H. Xu and Yiwei Li are named on this Form 483, for the inspection of Feb 14 – Feb 20, 2024. Each investigator has a profile showing what they cite most.
When was Simtra US LLC inspected by FDA?
The inspection ran Feb 14 – Feb 20, 2024, and the Form 483 is dated February 20, 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.