# FDA 483 - Novacyl Roussillon - July 04, 2014

Source: https://www.globalkeysolutions.net/records/483/novacyl-roussillon/cf157a47-19f0-4472-8dd8-25face6cc285

> FDA 483 for Novacyl Roussillon on July 04, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Novacyl Roussillon
- Inspection Date: 2014-07-04
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Novacyl, an API manufacturer in Roussillon, France, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into out-of-specification events, lack of equipment qualification, and insufficient calibration and monitoring procedures for environmental controls. These issues indicate a failure to maintain proper quality control and documentation practices.

## Related Documents

- [483 - 2016-06-27](https://www.globalkeysolutions.net/records/483/novacyl-roussillon/a2aae6a4-8c12-4fb5-b36f-b3ff7771f9ed)

## Related Officers

- [Team Biologics Staff](https://www.globalkeysolutions.net/people/linda-thai/f4d9a1c3-e5e8-4f13-8abe-e1f1e597c8f8)

Company: https://www.globalkeysolutions.net/companies/novacyl-roussillon/5a1bc6b5-5b17-4058-9698-82735b553d87

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321