# FDA 483 - Quality Chemical Laboratories - July 27, 2017

Source: https://www.keypedia.com/records/483/quality-chemical-laboratories/741293e4-2e30-43b1-8e28-8ab0df6bcbbd

> FDA 483 for Quality Chemical Laboratories on July 27, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quality Chemical Laboratories
- Inspection Date: 2017-07-27
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Quality Chemical Laboratories, LLC in Wilmington, NC, a contract testing laboratory and API manufacturer, identified significant deficiencies in their quality control unit and documentation practices. The firm failed to accurately record and follow up on audit findings, and did not document instrument usage in real-time as required by their procedures. These issues indicate a lack of adherence to established quality assurance and production control protocols.

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## Related Officers

- [Kara Dobbin](https://www.keypedia.com/people/kara-dobbin/0b35e025-4389-46df-abcb-30e70693f62b)
- [investigator](https://www.keypedia.com/people/tajah-l-blackburn/27b25d9d-3186-4b3a-a511-2f693d3c889a)

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