# FDA 483 - Novacyl Roussillon - June 27, 2016

Source: https://www.globalkeysolutions.net/records/483/novacyl-roussillon/a2aae6a4-8c12-4fb5-b36f-b3ff7771f9ed

> FDA 483 for Novacyl Roussillon on June 27, 2016. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Novacyl Roussillon
- Inspection Date: 2016-06-27
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: Novacyl, an active pharmaceutical manufacturer in Roussillon, France, received two observations during an FDA inspection in June 2016. The firm failed to thoroughly review batch failures related to impurity specifications for an API, and also had issues with equipment maintenance, including leaks and malfunctions, which contributed to product impurity failures. These observations indicate deficiencies in quality control and equipment management practices.

## Related Documents

- [483 - 2014-07-04](https://www.globalkeysolutions.net/records/483/novacyl-roussillon/cf157a47-19f0-4472-8dd8-25face6cc285)

## Related Officers

- [Russell J. Glapion](https://www.globalkeysolutions.net/people/russell-j-glapion/54dd6274-563a-44fe-8016-2ebd700be7a0)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552