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

Source: https://www.globalkeysolutions.net/records/483/contec-inc-sporicidin-division/940f1380-0427-4c54-9905-f47b2fc0d6d0

> FDA 483 for Contec Inc- Sporicidin Division on November 13, 2015. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contec Inc- Sporicidin Division
- Inspection Date: 2015-11-13
- Product Type: other
- Office Name: Atlanta District Office
- Summary: 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.

## Related Officers

- [Christopher B. May](https://www.globalkeysolutions.net/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)
- [Vascular Neurologist/Neurohospitalist/Medical Officer](https://www.globalkeysolutions.net/people/claudette-d-brooks/10f30b8f-2d20-4f92-84c1-862b31b81ce1)

Company: https://www.globalkeysolutions.net/companies/contec-inc-sporicidin-division/abdfa59d-214d-4910-8d63-d6b1ce3f5961

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7