FDA Inspection
TIGRIS Elektronik GmbHTIGRIS Elektronik GmbH – FDA Inspection, Sep 19, 2024
Record Details
This FDA Inspection record concerns TIGRIS Elektronik GmbH, with an inspection on September 19, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- TIGRIS Elektronik GmbH
- Inspection Date
- September 19, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · dc2a0012-ed1b-4030-8c8f-07bf16cd6906
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1250126
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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