Advanced Infusion Solutions
Form 483 issued September 14, 2020 · Clinton, Mississippi
- Inspection
- Sep 14, 2020
- Investigator
- June P. Page
- Observations
- 4
- Pages
- 3
- FEI number
- 3011469631
In short: On September 14, 2020, FDA issued a Form 483 with 4 observations to Advanced Infusion Solutions in Clinton, Mississippi (FEI 3011469631) after an inspection that ran Sep 14, 2020. The investigator was June P. Page. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 4 of 4 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 03
Protective apparel is not worn as necessary to protect…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
June P. Page
30 documents · 2015–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in India.
The firmAdvanced Infusion Solutions history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Infusion Solutions?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Advanced Infusion Solutions?
June P. Page is named on this Form 483, for the inspection of Sep 14, 2020. Each investigator has a profile showing what they cite most.
When was Advanced Infusion Solutions inspected by FDA?
The inspection ran Sep 14, 2020, and the Form 483 is dated September 14, 2020.
How do I get the full Form 483 for Advanced Infusion Solutions?
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.