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
View Company Profile
ID · 6db77d50-20a9-49a2-aeef-f4c54be9b156
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
- Radiation Control and Health Safety Act
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
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.