FDA Inspection 1256367 — IndeCon, Inc.
The FDA completed an inspection of IndeCon, Inc. on Dec 12, 2024 in Dallas, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12250 | 21 CFR 1271.55(d)(4) | Ten year retention |
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |