# Patheon Pharmaceuticals Inc. – FDA 483, Aug 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.

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## 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