FDA issued a Warning Letter to Nidek Inc on 8/8/2014 as a result of this inspection.
FDA investigators audited the Nidek - Fremont, CA, United States facility and issued 10 inspectional observations (via FDA 483) on 14 Apr 2014.
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- Category: Medical Devices & Rad Health
- Number of Observations: 10
- Inspection end: 14 Apr 2014
- Location: Fremont, United States
- FEI: 2936921