# FDA 483 - Kingchem Laboratories Inc. - October 18, 2021

Source: https://www.globalkeysolutions.net/records/483/kingchem-laboratories-inc/c8a9554e-e3e8-48d7-a564-f8d4c2e4b803

> FDA 483 for Kingchem Laboratories Inc. on October 18, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kingchem Laboratories Inc.
- Inspection Date: 2021-10-18
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: Kingchem Laboratories Inc., an API manufacturer in Saint Francis, WI, was cited for failing to follow its own written procedures for document control. Specifically, a cleaning log page was found in a laboratory notebook that was not issued by Quality Assurance, contrary to the firm's established good documentation practices. This indicates a breakdown in quality system adherence regarding document issuance.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/kingchem-laboratories-inc/6e67a9b1-b213-4da7-98e5-c1cf8d4862da)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)
- [Lori B. Wikstrom](https://www.globalkeysolutions.net/people/lori-b-wikstrom/19d938f7-4a5d-42b9-b2d1-e92cdb63bb0d)
- [Gregory R. Brinsley](https://www.globalkeysolutions.net/people/gregory-r-brinsley/4e0e1cf0-11c3-4440-bd40-d59fd648ef78)

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