# FDA 483 - Zochem ULC - July 20, 2023

Source: https://www.keypedia.com/records/483/zochem-ulc/2a6d59be-f02e-4ee8-8517-9ddc3f139721

> FDA 483 for Zochem ULC on July 20, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Zochem ULC
- Inspection Date: 2023-07-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Zochem ULC, an API manufacturer in Brampton, Ontario, was inspected by the FDA, revealing deficiencies in their raw material control processes. The inspection found that the firm accepted supplier analyses without proper validation and failed to adhere to its own procedures for qualifying new suppliers. These issues highlight a lack of robust quality control over incoming materials.

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Company: https://www.keypedia.com/companies/zochem-ulc/340a4f29-a236-486b-8f50-3e778fa2055f

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1