Iso-Tex Diagnostics, Inc.
Form 483 issued February 10, 2023 · Alvin, Texas
- Inspection
- Jan 30 – Feb 10, 2023
- Investigators
- Camerson E. Moore· Christopher N. Tran
- Observations
- 7
- Pages
- 7
- FEI number
- 1626310
In short: On February 10, 2023, FDA issued a Form 483 with 7 observations to Iso-Tex Diagnostics, Inc. in Alvin, Texas (FEI 1626310) after an inspection that ran Jan 30 – Feb 10, 2023. The investigators were Camerson E. Moore and Christopher N. Tran. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
5 of 7 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room…
- 04
Washing and toilet facilities lack air driers or…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Iso-Tex Diagnostics, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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.?
Camerson E. Moore and Christopher N. Tran are named on this Form 483, for the inspection of Jan 30 – Feb 10, 2023. Each investigator has a profile showing what they cite most.
When was Iso-Tex Diagnostics, Inc. inspected by FDA?
The inspection ran Jan 30 – Feb 10, 2023, and the Form 483 is dated February 10, 2023.
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.