Iso-Tex Diagnostics, Inc.
Form 483 issued January 31, 2018 · Alvin, Texas
- Inspection
- Jan 24 – Jan 31, 2018
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 1
- Pages
- 3
- FEI number
- 1626310
In short: On January 31, 2018, FDA issued a Form 483 with 1 observation to Iso-Tex Diagnostics, Inc. in Alvin, Texas (FEI 1626310) after an inspection that ran Jan 24 – Jan 31, 2018. The investigator was Patty P. Kaewussdangkul. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(vi) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
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 firmIso-Tex Diagnostics, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(vi)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Iso-Tex Diagnostics, Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 Iso-Tex Diagnostics, Inc.?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Jan 24 – Jan 31, 2018. Each investigator has a profile showing what they cite most.
When was Iso-Tex Diagnostics, Inc. inspected by FDA?
The inspection ran Jan 24 – Jan 31, 2018, and the Form 483 is dated January 31, 2018.
How do I get the full Form 483 for Iso-Tex Diagnostics, 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.