# FDA 483 - King Bio Inc. - July 28, 2023

Source: https://www.keypedia.com/records/483/king-bio-inc/5cb1ad08-3a10-47c9-9424-31d8262b29f8

> FDA 483 for King Bio Inc. on July 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: King Bio Inc.
- Inspection Date: 2023-07-28
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: King Bio Inc., a homeopathic drug product manufacturer in Asheville, NC, was inspected by the FDA. The inspection revealed significant issues with the firm's purified water system, which was found to be contaminated with objectionable microorganisms. Additionally, the quality control unit failed to follow established procedures for investigations, annual product reviews, and comprehensive consumer complaint assessments.

## Related Documents

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- [483 - 2021-08-12](https://www.keypedia.com/records/483/king-bio-inc/ca3ee48c-f2fe-455c-b702-3dc7d19ed52f)

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.keypedia.com/companies/king-bio-inc/bad7278d-85cb-43ee-99a5-4cb9b13a45ea

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7