# FDA 483 - Kingchem Laboratories Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/kingchem-laboratories-inc/6e67a9b1-b213-4da7-98e5-c1cf8d4862da

> FDA 483 for Kingchem Laboratories Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kingchem Laboratories Inc.
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Apiscent Labs, LLC, an API and Food Flavoring Manufacturer in St. Francis, WI, was cited for significant deficiencies across its quality system. The inspection revealed failures in quality control unit responsibilities, incomplete investigations into out-of-specification results and deviations, and inadequate procedures for raw material handling, supplier verification, and stability chamber management. These observations indicate a lack of robust controls to ensure product quality and compliance.

## Related Documents

- [483 - 2021-10-18](https://www.globalkeysolutions.net/records/483/kingchem-laboratories-inc/c8a9554e-e3e8-48d7-a564-f8d4c2e4b803)

## Related Officers

- [Performance Improvement Coordinator](https://www.globalkeysolutions.net/people/tenzin-jangchup/733eb315-0eeb-40ce-af6d-03b406a9235d)

Company: https://www.globalkeysolutions.net/companies/kingchem-laboratories-inc/576aa9b4-6874-49d6-af2c-5705b3848b0b

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d