Simtra US LLC
Form 483 issued November 10, 2021 · Bloomington, Indiana
- Inspection
- Nov 2 – Nov 10, 2021
- Investigators
- Brentley Collins· Burnell M. Henry· Scott Ballard
- Observations
- 3
- Pages
- 4
- FEI number
- 1000115571
In short: On November 10, 2021, FDA issued a Form 483 with 3 observations to Simtra US LLC in Bloomington, Indiana (FEI 1000115571) after an inspection that ran Nov 2 – Nov 10, 2021. The investigators were Brentley Collins, Burnell M. Henry and Scott Ballard. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
- 03
The Quality control unit lacks authority to fully investigate…
This inspection in context
Brentley Collins
11 documents · 2019–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Simtra US LLC?
FDA listed 3 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Simtra US LLC?
Brentley Collins, Burnell M. Henry and Scott Ballard are named on this Form 483, for the inspection of Nov 2 – Nov 10, 2021. Each investigator has a profile showing what they cite most.
When was Simtra US LLC inspected by FDA?
The inspection ran Nov 2 – Nov 10, 2021, and the Form 483 is dated November 10, 2021.
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.