FDA Inspection 998132 — IndeCon, Inc.
The FDA completed an inspection of IndeCon, Inc. on Nov 22, 2016 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 22, 2016
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Dallas, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12351 | 21 CFR 1271.190(d)(1) | Procedures for cleaning, sanitation |
| 12431 | 21 CFR 1271.265(e) | Procedures and release criteria |
| 12433 | 21 CFR 1271.265(f) | Return to inventory--procedures |
| 12457 | 21 CFR 1271.320(a) | Procedures re complaints |