Inventive Infusion Solutions, LP
Form 483 issued August 31, 2018 · San Antonio, Texas
- Inspection
- Aug 20 – Aug 31, 2018
- Investigator
- Uttaniti Limchumroon
- Observations
- 8
- Pages
- 4
- FEI number
- 3014498447
In short: On August 31, 2018, FDA issued a Form 483 with 8 observations to Inventive Infusion Solutions, LP in San Antonio, Texas (FEI 3014498447) after an inspection that ran Aug 20 – Aug 31, 2018. The investigator was Uttaniti Limchumroon. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
5 of 8 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (4×) · 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
Biological indicators are not used properly to verify the adequacy…
- 02
Endotoxin level is not tested on…
- 03
Non-sterilized and Non-depyrogenated equipment was used…
- 04
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities…
This inspection in context
Uttaniti Limchumroon
20 documents · 2015–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmInventive Infusion Solutions, LP 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 Inventive Infusion Solutions, LP?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Inventive Infusion Solutions, LP?
Uttaniti Limchumroon is named on this Form 483, for the inspection of Aug 20 – Aug 31, 2018. Each investigator has a profile showing what they cite most.
When was Inventive Infusion Solutions, LP inspected by FDA?
The inspection ran Aug 20 – Aug 31, 2018, and the Form 483 is dated August 31, 2018.
How do I get the full Form 483 for Inventive Infusion Solutions, LP?
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.