FDA Inspection
Iso-Tex Diagnostics, Inc.Iso-Tex Diagnostics, Inc. – FDA Inspection, Feb 10, 2023
Record Details
This FDA Inspection record concerns Iso-Tex Diagnostics, Inc., with an inspection on February 10, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c069fbcd-5897-4e83-b01a-8581af1f48d6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1197186
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
14- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.52Washing and toilet facilities are deficient
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
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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 7, 2020 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 29, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| January 31, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 1118892 - 2020-02-07
- FDA Inspection 1065390 - 2018-08-29
- FDA Inspection 1039153 - 2018-01-31
- FDA Inspection 934315 - 2015-07-10
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