I.V. Specialty Ltd.
Form 483 issued July 22, 2020 · Austin, Texas
- Inspection
- Jul 14, 2014 – Jul 22, 2020
- Investigator
- Lori G. Cantin
- Observations
- 10
- Pages
- 5
- FEI number
- 3010836489
In short: On July 22, 2020, FDA issued a Form 483 with 10 observations to I.V. Specialty Ltd. in Austin, Texas (FEI 3010836489) after an inspection that ran Jul 14, 2014 – Jul 22, 2020. The investigator was Lori G. Cantin. 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 7 of 10 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Clothing of personnel engaged in the manufacturing, processing, packing and holding of drug products is not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
Aseptic processing areas are deficient regarding the system…
- 04
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
This inspection in context
Lori G. Cantin
3 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmI.V. Specialty Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at I.V. Specialty Ltd.?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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 I.V. Specialty Ltd.?
Lori G. Cantin is named on this Form 483, for the inspection of Jul 14, 2014 – Jul 22, 2020. Each investigator has a profile showing what they cite most.
When was I.V. Specialty Ltd. inspected by FDA?
The inspection ran Jul 14, 2014 – Jul 22, 2020, and the Form 483 is dated July 22, 2020.
How do I get the full Form 483 for I.V. Specialty Ltd.?
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.