# FDA 483 - Gold Bond Inc. - December 04, 2024

Source: https://www.keypedia.com/records/483/gold-bond-inc/60c678b3-e9a4-4e8b-864b-771a6d3e4ec2

> FDA 483 for Gold Bond Inc. on December 04, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Gold Bond Inc.
- Inspection Date: 2024-12-04
- Product Type: drugs
- Office Name: Food and Drug Administration
- Summary: During an inspection from December 2nd to December 4th, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Gold Bond Inc., a repacker/relabeler based in Hixson, TN. The observations indicated significant deviations from current Good Manufacturing Practices (cGMP) for drug products, specifically concerning their Stick Spray Hand Sanitizer.

The primary violation noted was the absence of an adequate Quality Control Unit. Gold Bond Inc. failed to establish a functional Quality Unit with defined responsibilities and authority to oversee labeling and handling, lacking essential procedures for change control, investigations, complaint handling, and employee training. Critically, the firm distributed multiple batches of expired Stick Spray Hand Sanitizer to the U.S. market in 2024, demonstrating a severe lapse in quality oversight.

Additionally, the inspection revealed a failure to establish written procedures for production and process controls, specifically lacking process validation for labeling, bagging, and ink screen cleaning processes. Deficiencies also extended to the Facilities and Equipment System, where the company had not established written procedures for the preventative maintenance and cleaning of equipment, such as the bagger, used in packaging. Gold Bond Inc. is required to implement comprehensive corrective actions to address these systemic issues and ensure compliance with FDA regulations.

## Related Documents

- [483 - 2024-12-04](https://www.keypedia.com/records/483/gold-bond-inc/3123749d-a1d9-4e1a-9680-1a81fa6e808a)

## Related Officers

- [Director](https://www.keypedia.com/people/joann-m/0a459cd4-7849-4687-8811-4868144e3be3)

Company: https://www.keypedia.com/companies/gold-bond-inc/2b461f97-37a3-4836-84bc-11c049989be3

Office: https://www.keypedia.com/offices/food-and-drug-administration/437fdb2a-5048-42aa-aaea-ea28efe65516