FDA Inspection
Kali LLCKali LLC – FDA Inspection, Jun 20, 2018
Record Details
This FDA Inspection record concerns Kali LLC, with an inspection on June 20, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7ef1ca2f-3c6c-475e-867e-98e4139155f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056245
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.70(d)Training temp work under special environmental conditions
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.60Identification procedures, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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