FDA Inspection
CK Warmy LLC. dba WarForce USACK Warmy LLC. dba WarForce USA – FDA Inspection, Oct 11, 2022
Record Details
This FDA Inspection record concerns CK Warmy LLC. dba WarForce USA, with an inspection on October 11, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 11, 2022
- Product Type
- Devices
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ID · 6038398c-11f6-48ae-90dc-00dfa83615a5
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1181370
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
FDA Citations
7- 21 CFR 1010.2(b)Certification label or tag
- 21 CFR 1010.3(a)ID label or tag
- 21 CFR 1040.10(g)(2)(i)Class IIIa "Caution" label
- 21 CFR 1040.11(b)Surveying, leveling, alignment laser products
- 21 CFR 1040.10(g)(5)(i)Aperture label - laser radiation
- 21 CFR 1002.13Failure to submit
- 21 CFR 1002.10Failure to submit, distinct marking
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