FDA Inspection 797921 — Iso-Tex Diagnostics, Inc.
The FDA completed an inspection of Iso-Tex Diagnostics, Inc. on Sep 7, 2012 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
- Sep 7, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Alvin, TX (United States)
Additional Details
Postmarket Adverse Drug Experience (PADE)
Citations
| ID | CFR | Description |
|---|---|---|
| 6830 | 21 CFR 314.80(c)(2) | Interval |