FDA Inspection
Citagenix Inc.Citagenix Inc. – FDA Inspection, Jan 14, 2016
Record Details
This FDA Inspection record concerns Citagenix Inc., with an inspection on January 14, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Citagenix Inc.
- Inspection Date
- January 14, 2016
- Product Type
- Devices
View Company Profile
ID · e462d66d-bf9c-4ec2-9290-2976ceaece2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 958313
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.120Lack of or inadequate procedures for labeling
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Citagenix Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 23, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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