# FDA 483 - Cosmax USA, Inc. - September 20, 2017

Source: https://www.globalkeysolutions.net/records/483/cosmax-usa-inc/7ddd5353-f4b8-42e6-89ad-6e8a1a3f6ab7

> FDA 483 for Cosmax USA, Inc. on September 20, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmax USA, Inc.
- Inspection Date: 2017-09-20
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Nu-World Corporation, an OTC drug manufacturer in Carteret, NJ, revealed significant deficiencies in their quality systems. The firm failed to thoroughly investigate out-of-specification product yields and lacked adequate controls over computer systems and change management. Additionally, the inspection found a lack of GMP training for contract employees and insufficient long-term stability studies to support product expiration dates.

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## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.globalkeysolutions.net/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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

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