FDA Inspection
Litron LLCLitron LLC – FDA Inspection, Mar 22, 2022
Record Details
This FDA Inspection record concerns Litron LLC, with an inspection on March 22, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Litron LLC
- Inspection Date
- March 22, 2022
- Product Type
- Devices
View Company Profile
ID · fe3027cd-2f45-4c4c-ab7c-f6a8c3b7dedc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1165118
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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