FDA issued a Warning Letter to Gulf Medical Fiberoptics, Inc. on 7/27/2011 as a result of this inspection.
FDA investigators audited the Gulf Fiberoptics - Oldsmar, FL, United States facility and issued 12 inspectional observations (via FDA 483) on 03 May 2011.
Product details
- Category: Medical Devices & Rad Health
- Number of Observations: 12
- Inspection end: 03 May 2011
- Location: Oldsmar, United States
- FEI: 3003768921
