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

Source: https://www.keypedia.com/records/483/thermofisher-scientific-dba-patheon-softgels-inc/d810abd1-7ba1-479d-92c4-10cbb3100d6f

> FDA 483 for ThermoFisher Scientific dba 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: ThermoFisher Scientific dba Patheon Softgels Inc.
- Inspection Date: 2025-07-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: During an inspection conducted from July 7 to July 17, 2025, the FDA issued a Form 483 to ThermoFisher Scientific dba Patheon Softgels Inc., identifying significant observations regarding their manufacturing practices. These observations suggest potential deviations from current Good Manufacturing Practices (GMP).

The main issues included a lack of established and followed written procedures for equipment cleaning and maintenance. Specifically, cleaning logs for the Manufacturing Suite Room lacked required visual inspection data and verification of cleaning effectiveness, and quality personnel had not timely reviewed these records.

Furthermore, the Quality Control unit failed to fully adhere to its responsibilities and procedures. Microbiology laboratory notebooks were incomplete, missing Quality Assurance signatures and timely closure as mandated by the firm's own Standard Operating Procedures. This specific deficiency was noted as a repeat observation from a prior 2019 inspection.

Finally, batch production and control records were found to be deficient. A review of a GEL Batch Control Record revealed missing documentation for significant manufacturing steps, such as the addition of key ingredients. The batch record had not been updated to reflect the actual, approved manufacturing processes, which now incorporate an automated system.

The company is required to implement appropriate corrective actions to address these observations and ensure compliance with regulatory standards.

## 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/thermofisher-scientific-dba-patheon-softgels-inc/27a73adb-afb8-48d7-b66b-0f0396827274

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