Resource Optimization & Innovation, LLC
Form 483 issued November 29, 2016 · Springfield, Missouri
- Inspection
- Nov 7 – Nov 29, 2016
- Investigator
- Michele Perry Williams
- Observations
- 6
- Pages
- 5
- FEI number
- 3004513970
In short: On November 29, 2016, FDA issued a Form 483 with 6 observations to Resource Optimization & Innovation, LLC in Springfield, Missouri (FEI 3004513970) after an inspection that ran Nov 7 – Nov 29, 2016. The investigator was Michele Perry Williams. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 4 of 6 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 are…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Michele Perry Williams
22 documents · 2009–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmResource Optimization & Innovation, LLC history
All 2 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 Resource Optimization & Innovation, LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Resource Optimization & Innovation, LLC?
Michele Perry Williams is named on this Form 483, for the inspection of Nov 7 – Nov 29, 2016. Each investigator has a profile showing what they cite most.
When was Resource Optimization & Innovation, LLC inspected by FDA?
The inspection ran Nov 7 – Nov 29, 2016, and the Form 483 is dated November 29, 2016.
How do I get the full Form 483 for Resource Optimization & Innovation, 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.