# FDA 483 - AX Pharmaceutical Corporation - May 06, 2022

Source: https://www.keypedia.com/records/483/ax-pharmaceutical-corporation/2c4a5ed7-8c54-43c8-973e-89b683620bc2

> FDA 483 for AX Pharmaceutical Corporation on May 06, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AX Pharmaceutical Corporation
- Inspection Date: 2022-05-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: AX Pharmaceutical Corporation, a repackager, relabeler, and broker/trader of drug substances in Concord, Ontario, was cited for significant deficiencies across its quality system. Observations included inadequate record-keeping for API traceability, lack of quality unit oversight, deficient self-inspection programs, and unvalidated computerized systems. The firm also lacked essential written procedures for quality unit definition, complaint handling, API traceability, and qualification of outsourced service providers.

## Related Officers

- [Investigator](https://www.keypedia.com/people/kham-phommachanh/cc7e728e-d2a1-469d-be3a-4f5fdd43b2dc)

Company: https://www.keypedia.com/companies/ax-pharmaceutical-corporation/edd09f02-a326-4fd4-9b78-0db6bd74b76d

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