# FDA 483 - Patheon Softgels Inc. - July 17, 2025

Source: https://www.keypedia.com/records/483/patheon-softgels-inc/4f88737c-2d35-45cb-8564-ff4184f245b2

> FDA 483 for Patheon Softgels Inc. on July 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Softgels Inc.
- Inspection Date: 2025-07-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: An FDA inspection of ThermoFisher Scientific dba Patheon Softgels Inc in High Point, NC, from July 7-17, 2025, revealed significant deficiencies in quality control and manufacturing documentation. Observations included a failure to follow established cleaning and maintenance procedures for equipment, incomplete Quality Control Microbiology Laboratory notebooks lacking QA signatures and timely review, and deficient batch production records that did not accurately document manufacturing steps. These issues indicate a lack of adherence to established procedures and proper record-keeping practices.

## Related Officers

- [J'Maica J. Hunter](https://www.keypedia.com/people/jmaica-j-hunter/173f731f-4dc4-4ef2-8cb3-72993cb91119)
- [investigator](https://www.keypedia.com/people/daveta-l-bailey/b3c06872-638b-4c47-9539-a93b819be23f)

Company: https://www.keypedia.com/companies/patheon-softgels-inc/10cb6876-0398-4373-a33a-1d1e4c2bcf82

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7