Advanced Infusion Solutions
Form 483 issued January 18, 2023 · Dallas, Texas
- Inspection
- Jan 18, 2023
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 3
- FEI number
- 3017983596
In short: On January 18, 2023, FDA issued a Form 483 with 3 observations to Advanced Infusion Solutions in Dallas, Texas (FEI 3017983596) after an inspection that ran Jan 18, 2023. The investigator was Patty P. Kaewussdangkul. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Non-depyrogenated tools were used…
- 02
You did not make adequate product evaluation and take remedial action where actionable particle counts were…
- 03
Poor cleaning practices observed…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmAdvanced Infusion Solutions history
The site's inspection history, in date order.
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 Advanced Infusion Solutions?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. 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 Advanced Infusion Solutions?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Jan 18, 2023. Each investigator has a profile showing what they cite most.
When was Advanced Infusion Solutions inspected by FDA?
The inspection ran Jan 18, 2023, and the Form 483 is dated January 18, 2023.
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.