FDA Inspection
Optical Connection LLCOptical Connection LLC – FDA Inspection, Jan 16, 2020
Record Details
This FDA Inspection record concerns Optical Connection LLC, with an inspection on January 16, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Optical Connection LLC
- Inspection Date
- January 16, 2020
- Product Type
- Devices
View Company Profile
ID · 4226fc39-013d-423c-932a-69545fb0d27a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1115579
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)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
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