Contec Inc- Sporicidin DivisionNovember 13, 2015

FDA 483 - Contec Inc- Sporicidin Division - November 13, 2015

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Record Details

An FDA inspection of Contec Inc- Sporicidin Division in Spartanburg, SC, a specification developer, revealed significant deficiencies in its quality system. The firm failed to perform quality audits at defined intervals and in accordance with established procedures. Additionally, the results and dates of management reviews were not properly documented, and the CEO did not participate in a required review.

Company: Contec Inc- Sporicidin Division
Inspection Date: November 13, 2015
Product Type: Other
Office: Atlanta District Office
People: Christopher B. May
Claudette D. Brooks (Vascular Neurologist/Neurohospitalist/Medical Officer)

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ID · 940f1380-0427-4c54-9905-f47b2fc0d6d0