Innoveix Pharmaceuticals Inc.
Form 483 issued September 12, 2019 · Addison, Texas
- Inspection
- Aug 27, 2019
- Investigator
- Jason R. Caballero
- Observations
- 9
- Pages
- 6
- FEI number
- 3012907473
In short: On September 12, 2019, FDA issued a Form 483 with 9 observations to Innoveix Pharmaceuticals Inc. in Addison, Texas (FEI 3012907473) after an inspection that ran Aug 27, 2019. The investigator was Jason R. Caballero. 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 (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
Un-protected product intended to be sterile was exposed to lower than ISO 5 classified aseptic…
- 02
Your facility design allowed the influx of poor quality air into…
- 03
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
- 04
Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) 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 and facilities & equipment. 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.?
Jason R. Caballero is named on this Form 483, for the inspection of Aug 27, 2019. Each investigator has a profile showing what they cite most.
When was Innoveix Pharmaceuticals Inc. inspected by FDA?
The inspection ran Aug 27, 2019, and the Form 483 is dated September 12, 2019.
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.