Simtra US LLC
Form 483 issued May 23, 2018 · Bloomington, Indiana
- Inspection
- May 16 – May 23, 2018
- Investigators
- Simone E. Pitts· Susan M. Jackson
- Observations
- 4
- Pages
- 4
- FEI number
- 1000115571
In short: On May 23, 2018, FDA issued a Form 483 with 4 observations to Simtra US LLC in Bloomington, Indiana (FEI 1000115571) after an inspection that ran May 16 – May 23, 2018. The investigators were Simone E. Pitts and Susan M. Jackson. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and laboratory controls account for 3 of 4 observations.
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 do not include…
- 02
Media fill batch manufacturing record 930381 executed to simulate the manufacturing process for Fluzone QIV- IM…
- 03
There is no written testing program designed to assess the stability…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Simone E. Pitts
18 documents · 2014–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Illinois.
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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Simtra US LLC?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Simtra US LLC?
Simone E. Pitts and Susan M. Jackson are named on this Form 483, for the inspection of May 16 – May 23, 2018. Each investigator has a profile showing what they cite most.
When was Simtra US LLC inspected by FDA?
The inspection ran May 16 – May 23, 2018, and the Form 483 is dated May 23, 2018.
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.