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, covering devices.
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ID · 115838b5-897a-4143-94df-21ded537f297
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1247208
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: 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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