FDA Inspection
Iso-Tex Diagnostics, Inc.Iso-Tex Diagnostics, Inc. – FDA Inspection, Jan 31, 2018
Record Details
This FDA Inspection record concerns Iso-Tex Diagnostics, Inc., with an inspection on January 31, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 9de301c2-a069-40ed-b636-6d98c218dad7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039153
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
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Other FDA inspections of Iso-Tex Diagnostics, Inc.
11| Date | Classification | Office | Project area |
|---|---|---|---|
| February 3, 2026 | OAI | Dallas District Office | Drug Quality Assurance |
| February 10, 2023 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 29, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 10, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Iso-Tex Diagnostics, Inc.
- FDA Inspection 1301096 - 2026-02-03
- FDA Inspection 1197186 - 2023-02-10
- FDA Inspection 1118892 - 2020-02-07
- FDA Inspection 1065390 - 2018-08-29
- FDA Inspection 934315 - 2015-07-10
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