FDA issued a Warning Letter to Somnowell, Inc. on 5/12/2016 as a result of this inspection.
FDA investigators audited the Somnowell - Bellevue, TN, United States facility and issued 9 inspectional observations (via FDA 483) on 10 Mar 2016.
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- Category: Medical Devices & Rad Health
- Number of Observations: 9
- Inspection end: 10 Mar 2016
- Location: Bellevue, United States
- FEI: 3011669995