FDA Inspection
ITxM Clinical ServicesITxM Clinical Services – FDA Inspection, Jan 29, 2015
Record Details
This FDA Inspection record concerns ITxM Clinical Services, with an inspection on January 29, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- ITxM Clinical Services
- Inspection Date
- January 29, 2015
- Product Type
- Biologics
View Company Profile
ID · 0c01fdc4-538c-4cb7-94d7-20b7dd9aa2e6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 908695
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(b)Required records
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ITxM Clinical Services
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 23, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for ITxM Clinical Services
- FDA Inspection 1010228 - 2017-03-30
- FDA Inspection 1008797 - 2017-03-23
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