FDA Inspection
Hamamatsu Photonics K.K., Systems DivisionHamamatsu Photonics K.K., Systems Division – FDA Inspection, Feb 9, 2017
Record Details
This FDA Inspection record concerns Hamamatsu Photonics K.K., Systems Division, with an inspection on February 9, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- February 9, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · f0b85045-4faa-40e2-b49c-9c99a9c207ae
Inspection Facts
- Inspection number
- 1006010
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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