# FDA 483 - Cosmax USA, Inc. - December 22, 2014

Source: https://www.keypedia.com/records/483/cosmax-usa-inc/ea5026c9-762d-4278-9057-639415d1315e

> FDA 483 for Cosmax USA, Inc. on December 22, 2014. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmax USA, Inc.
- Inspection Date: 2014-12-22
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Nu-World Corporation, a drug product manufacturer in Carteret, NJ, revealed several significant deficiencies. Observations included an inadequate written stability program lacking specific test methods, insufficient controls over computer systems for master production records, and a failure to investigate unexplained discrepancies. Additionally, master production and control records lacked theoretical yield statements with required investigation limits.

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## Related Officers

- [Advisor](https://www.keypedia.com/people/frederick-razzaghi/7346f6ec-1d9a-4ad3-abde-0497dcd9c8b5)

Company: https://www.keypedia.com/companies/cosmax-usa-inc/07864b04-8b51-48e2-9b98-690427e85a49

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248