# FDA 483 - IntelliPharmaCeutics Corp. - June 14, 2019

Source: https://www.keypedia.com/records/483/intellipharmaceutics-corp/403cc2b4-473f-41ed-aa24-59a66e7b0054

> FDA 483 for IntelliPharmaCeutics Corp. on June 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IntelliPharmaCeutics Corp.
- Inspection Date: 2019-06-14
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Intellipharmaceutics Corp., a drug manufacturer in Toronto, Ontario, revealed significant deficiencies across multiple systems. Observations included inadequate equipment cleaning and validation, compromised data integrity in laboratory computer systems, and an improperly designed sampling booth. The firm also failed to follow written procedures for complaint investigations and environmental monitoring, and lacked scientifically sound sampling plans and hold time justifications.

## Related Officers

- [Manager](https://www.keypedia.com/people/qin-xu/176a88a7-a11e-4374-a64a-378806e76d84)

Company: https://www.keypedia.com/companies/intellipharmaceutics-corp/78f18be2-f4f4-44f4-88d7-30d9f8f36ac5

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