# FDA 483 - Patheon Pharmaceuticals Inc. - August 21, 2015

Source: https://www.keypedia.com/records/483/patheon-pharmaceuticals-inc/ff3273cc-2273-45b6-8a2e-d844f29091ab

> FDA 483 for Patheon Pharmaceuticals Inc. on August 21, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Pharmaceuticals Inc.
- Inspection Date: 2015-08-21
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: Patheon Pharmaceuticals Inc. in Cincinnati, OH, a manufacturer, was cited for significant data integrity and procedural compliance issues during an FDA inspection. Observations included a lack of complete audit trails for networked HPLC testing and unrecorded sample injections, failure to follow standard operating procedures for chromatography data systems, and inadequate checks for computer input/output accuracy in manufacturing. These findings indicate serious deficiencies in record-keeping and adherence to established controls.

## Related Documents

- [EIR - 2017-03-01](https://www.keypedia.com/records/eir/patheon-pharmaceuticals-inc/ffc3b2b8-6ab9-456d-b78d-b6e30aeea171)
- [EIR - 2018-02-14](https://www.keypedia.com/records/eir/patheon-pharmaceuticals-inc/ab7af48a-5395-4a10-a459-61234e9edc2d)
- [483 - 2018-02-14](https://www.keypedia.com/records/483/patheon-pharmaceuticals-inc/9eb0faa4-5afb-406b-95a3-d30d918be7c5)
- [EIR - 2019-12-13](https://www.keypedia.com/records/eir/patheon-pharmaceuticals-inc/50927805-589f-47bc-9191-0bf4eb7b953a)
- [EIR - 2020-01-14](https://www.keypedia.com/records/eir/patheon-pharmaceuticals-inc/cdf1e925-9a0e-4d8c-8130-30ad1223c5c7)

## Related Officers

- [Tarun D. Mehta](https://www.keypedia.com/people/tarun-d-mehta/4fddfee9-7083-4089-b298-f7536b8d9b73)
- [Investigator ](https://www.keypedia.com/people/lindsey-schwierjohann/3608e7c0-5bb9-49f0-844d-ddd6f6724fdb)

Company: https://www.keypedia.com/companies/patheon-pharmaceuticals-inc/f1ef6b53-3c20-4c22-9ef3-fd05fdb9f35b

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22