# FDA 483 - JC World Bell  Co., Inc. - September 09, 2020

Source: https://www.globalkeysolutions.net/records/483/jc-world-bell-co-inc/516ad543-cdeb-4dee-9f63-828b7fbefd7c

> FDA 483 for JC World Bell  Co., Inc. on September 09, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: JC World Bell  Co., Inc.
- Inspection Date: 2020-09-09
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: During an inspection from August 31 to September 9, 2020, JC World Bell Co., Inc. in Hackensack, NJ, an OTC secondary repacker/distributor, was cited for significant deficiencies in its quality control unit and batch production records. The firm failed to follow written procedures, distributed recalled products, and maintained incomplete batch records, indicating a lack of adequate controls over its drug product operations.

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- [483 - 2024-11-19](https://www.globalkeysolutions.net/records/483/jc-world-bell-co-inc/752f9a75-6085-4834-be1c-ba14572a63c0)

## Related Officers

- [Yvesna Blaise](https://www.globalkeysolutions.net/people/yvesna-blaise/4cd6b7c2-78a7-490d-9354-52046bc7344f)

Company: https://www.globalkeysolutions.net/companies/jc-world-bell-co-inc/b39aec05-6ecf-4824-8ac7-f350ce378361

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