FDA issued a Warning Letter to Impladent Ltd. on 3/28/2014 as a result of this inspection.
FDA investigators audited the Impladent - Jamaica, NY, United States facility and issued 3 inspectional observations (via FDA 483) on 26 Sep 2013.
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- Category: Medical Devices & Rad Health
- Number of Observations: 3
- Inspection end: 26 Sep 2013
- Location: Jamaica, United States
- FEI: 2431866