# FDA 483 - King Bio Inc. - August 12, 2021

Source: https://www.keypedia.com/records/483/king-bio-inc/ca3ee48c-f2fe-455c-b702-3dc7d19ed52f

> FDA 483 for King Bio Inc. on August 12, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: King Bio Inc.
- Inspection Date: 2021-08-12
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of King Bio Inc. in Asheville, NC, from August 2-12, 2021, resulted in a Form 483 listing seven observations, including three repeat observations. The findings highlight significant deficiencies across the firm's quality system, encompassing inadequate investigation procedures, a lack of process validation, insufficient employee training, and issues with equipment qualification, material inventory, component identity testing, and hold time studies. These observations collectively indicate a need for improved controls and adherence to good manufacturing practices for drug product production.

## Related Documents

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## Related Officers

- [Owner/Inspector](https://www.keypedia.com/people/jared-p-stevens/11cd48ff-e61f-4448-98be-efe2f8377fc1)
- [Director of Inspection Readiness](https://www.keypedia.com/people/bonita-s-chester/cc6ce6f4-bb5c-452a-820c-3339361bc8b2)

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