# FDA 483 - Hanam International LLC - October 02, 2017

Source: https://www.globalkeysolutions.net/records/483/hanam-international-llc/96b41bad-cf8e-43a7-b68a-d11123fbd5d6

> FDA 483 for Hanam International LLC on October 02, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Hanam International LLC
- Inspection Date: 2017-10-02
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: Hanam International LLC, a wholesale distributor and relabeler in Ridgefield, NJ, was cited for significant deficiencies in its quality system and material handling. The inspection revealed a complete absence of a quality control unit and written procedures for critical operations such as complaint handling, warehousing, and distribution. These issues indicate a fundamental lack of control over drug product quality and accountability.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.globalkeysolutions.net/companies/hanam-international-llc/e7a6ed58-ab7a-4be5-85f2-5d8c378f3d7f

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