Innoveix Pharmaceuticals Inc.
Form 483 issued May 27, 2021 · Addison, Texas
- Inspection
- May 11 – May 27, 2021
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 9
- Pages
- 6
- FEI number
- 3012907473
In short: On May 27, 2021, FDA issued a Form 483 with 9 observations to Innoveix Pharmaceuticals Inc. in Addison, Texas (FEI 3012907473) after an inspection that ran May 11 – May 27, 2021. The investigator was Patty P. Kaewussdangkul. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 8 of 9 observations.
Most cited: 21 CFR 211.113 (5×) · 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Personnel conducted aseptic manipu lations in an area that blocked movement of first pass air around…
- 03
(b)(4) is not sterilized by routine sterilization cycles and cleaning process of…
- 04
Failure to conduct media fills that closely simulate aseptic production operations under the worst-case…
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 firmInnoveix Pharmaceuticals Inc. history
All 3 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 Innoveix Pharmaceuticals Inc.?
FDA listed 9 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 Innoveix Pharmaceuticals Inc.?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of May 11 – May 27, 2021. Each investigator has a profile showing what they cite most.
When was Innoveix Pharmaceuticals Inc. inspected by FDA?
The inspection ran May 11 – May 27, 2021, and the Form 483 is dated May 27, 2021.
How do I get the full Form 483 for Innoveix Pharmaceuticals Inc.?
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.