FDA Inspection 1301096 — Iso-Tex Diagnostics, Inc.
The FDA completed an inspection of Iso-Tex Diagnostics, Inc. on February 3, 2026 in Alvin, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 3, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alvin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |