# FDA 483 - Quality Chemical Laboratories - November 20, 2024

Source: https://www.keypedia.com/records/483/quality-chemical-laboratories/d7ce1e9a-dc21-45cf-bd04-c6393b34f523

> FDA 483 for Quality Chemical Laboratories on November 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quality Chemical Laboratories
- Inspection Date: 2024-11-20
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Quality Chemical Laboratories in Wilmington, NC, a contract testing laboratory and manufacturer, revealed two significant observations. The firm was cited for inadequate qualification of an oven used for depyrogenation and for failing to conduct comprehensive root cause analyses for failed endotoxin results. These issues indicate deficiencies in equipment validation and quality unit investigation practices.

## Related Documents

- [483 - 2017-07-27](https://www.keypedia.com/records/483/quality-chemical-laboratories/741293e4-2e30-43b1-8e28-8ab0df6bcbbd)

## Related Officers

- [Oluwasefunmi Agbanigo](https://www.keypedia.com/people/oluwasefunmi-agbanigo/096acae0-9835-4ff1-8faa-c5ec6f551b21)
- [Drug Specialist  / Drug Investigator](https://www.keypedia.com/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.keypedia.com/companies/quality-chemical-laboratories/57f7f773-23e6-4d97-9621-b65592c11e62

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