FDA Inspection
CYTOVALE INCCYTOVALE INC – FDA Inspection, Oct 13, 2026
Record Details
This FDA Inspection record concerns CYTOVALE INC, with an inspection on October 13, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CYTOVALE INC
- Inspection Date
- October 13, 2026
- Product Type
- Devices
View Company Profile
ID · d26f9844-69b5-48d0-9c0b-5ef89d00ea15
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1340946
- Project area
- Compliance: Devices
FDA Citations
3- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 4.1.3External party controls do not include written quality agreements
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
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