# FDA 483 - JC World Bell  Co., Inc. - November 19, 2024

Source: https://www.keypedia.com/records/483/jc-world-bell-co-inc/752f9a75-6085-4834-be1c-ba14572a63c0

> FDA 483 for JC World Bell  Co., Inc. on November 19, 2024. 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: 2024-11-19
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of JC World Bell Co., Inc., an OTC secondary repacker/distributor in Hackensack, NJ, revealed significant deficiencies in their quality control unit, production and process controls, and equipment calibration. The firm failed to validate packaging processes, perform routine weight verification for analytical balances, and ensure proper review of warehouse qualification documents by the Quality Unit. These issues indicate a lack of adequate controls to assure drug product quality and compliance.

## Related Documents

- [483 - 2020-09-09](https://www.keypedia.com/records/483/jc-world-bell-co-inc/516ad543-cdeb-4dee-9f63-828b7fbefd7c)

## Related Officers

- [Josh Renzo N. Ramilo](https://www.keypedia.com/people/josh-renzo-n-ramilo/5b0850ba-e22a-42fc-9310-2beeb921f8f6)
- [Tomika L. Crafter](https://www.keypedia.com/people/tomika-l-crafter/6c8260a0-c026-496d-80f6-9c30877e8f52)

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

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