FDA Inspection
Iso-Tex Diagnostics, Inc.Iso-Tex Diagnostics, Inc. – FDA Inspection, Jul 10, 2015
Record Details
This FDA Inspection record concerns Iso-Tex Diagnostics, Inc., with an inspection on July 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Iso-Tex Diagnostics, Inc.
- Inspection Date
- July 10, 2015
- Product Type
- Drugs
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ID · c942d4be-2b0e-483a-9fb5-0edb0e1e6b39
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 934315
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.56(b)Written sanitation procedures lacking
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.182Written records kept in individual logs
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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 |
| January 31, 2018 | VAI | 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 1039153 - 2018-01-31
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