www.fdanews.com/articles/177687-oscor-gets-warning-letter-over-quality-system-issues
Oscor Gets Warning Letter Over Quality System Issues
July 26, 2016
Failure to control its production processes and to validate them properly landed devicemaker Oscor an FDA warning letter for quality system deficiencies.
The letter cites the Palm Harbor, Fla.-based company for failing to develop, conduct, control and monitor production processes to ensure devices conform to specifications. — Tamra Sami