# Iso-Tex Diagnostics, Inc. – FDA Inspection, Feb 10, 2023

Source: https://www.keypedia.com/records/fda_inspections/iso-tex-diagnostics-inc/c069fbcd-5897-4e83-b01a-8581af1f48d6
Source feed: FDA_Inspections

> FDA inspection 1197186 of Iso-Tex Diagnostics, Inc., February 10, 2023. Classification: Official Action Indicated (OAI). 14 citations under 21 CFR part 211. Form 483 issued. 11 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1197186
- Company Name: Iso-Tex Diagnostics, Inc.
- Inspection Date: 2023-02-10
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Drug Quality Assurance
- Product Type: Drugs
- Center: Human Drugs
- Office Name: Center for Drug Evaluation and Research
- Citation Count: 14
- Enforcement Type: WARNING_LETTER

## Related Documents

- [FDA Inspection 1301096 - 2026-02-03](https://www.keypedia.com/records/fda_inspections/iso-tex-diagnostics-inc/08148445-6692-4e57-a8a3-dca5e0c98677)
- FDA Inspection 1118892 - 2020-02-07
- FDA Inspection 1065390 - 2018-08-29
- [FDA Inspection 1039153 - 2018-01-31](https://www.keypedia.com/records/fda_inspections/iso-tex-diagnostics-inc/9de301c2-a069-40ed-b636-6d98c218dad7)
- [FDA Inspection 934315 - 2015-07-10](https://www.keypedia.com/records/fda_inspections/iso-tex-diagnostics-inc/c942d4be-2b0e-483a-9fb5-0edb0e1e6b39)

## Related Officers

- [FDA Associated Person](https://www.keypedia.com/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)
- [Christopher N. Tran](https://www.keypedia.com/people/christopher-n-tran/af702ab8-dd76-4b21-ac0f-f282de645103)

Company: https://www.keypedia.com/companies/iso-tex-diagnostics-inc/59c59676-32cc-4749-b95d-3bdc31559b58

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c