FDA Inspection
IDS LTDFDA Inspection 1247208 - IDS LTD - August 23, 2024
Record Details
This FDA Inspection record concerns IDS LTD, with an inspection on August 23, 2024, issued by the Center for Devices and Radiological Health.
- Company
- IDS LTD
- Inspection Date
- August 23, 2024
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ID · f157464e-0d19-4e14-82e6-c4167f45fc54
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1247208
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 1040.10(f)(5)(ii)Emission indicator - Class IIIb & IV
- 21 CFR 1040.10(f)(3)Remote interlock connector
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - software validation not performed
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