I.V. Specialty Ltd.
Form 483 issued July 28, 2017 · Austin, Texas
- Inspection
- Jul 24 – Jul 28, 2017
- Investigators
- Nimmy Mathews· Scott Ballard
- Observations
- 6
- Pages
- 3
- FEI number
- 3010836489
In short: On July 28, 2017, FDA issued a Form 483 with 6 observations to I.V. Specialty Ltd. in Austin, Texas (FEI 3010836489) after an inspection that ran Jul 24 – Jul 28, 2017. The investigators were Nimmy Mathews and Scott Ballard. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.56 (sanitation).
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.56 (2×) · 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
Vermin was observed present in areas immediately adjacent…
- 02
The ISO-classified have difficult to clean, particle-generating, or visibly dirty equipment or surfaces. 4 A. LAF…
- 03
Aseptic practices in critical area are not adequate for sterile drug processing…
- 04
Cleaning or Sanitizing of ISO 7 clean room is not adequate…
This inspection in context
Nimmy Mathews
5 documents · 2017–2020
Cites 211.113 (control of microbiological contamination) 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 211.56
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at I.V. Specialty Ltd.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.56 (sanitation). The opening words of each observation are shown on this page.
Who inspected I.V. Specialty Ltd.?
Nimmy Mathews and Scott Ballard are named on this Form 483, for the inspection of Jul 24 – Jul 28, 2017. Each investigator has a profile showing what they cite most.
When was I.V. Specialty Ltd. inspected by FDA?
The inspection ran Jul 24 – Jul 28, 2017, and the Form 483 is dated July 28, 2017.
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.