FDA Inspection 1039153 — Iso-Tex Diagnostics, Inc.
The FDA completed an inspection of Iso-Tex Diagnostics, Inc. on Jan 31, 2018 in Alvin, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 31, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Alvin, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1436 | 21 CFR 211.42(c)(10)(vi) | Equipment to control conditions |