# FDA 483 - Exxonmobil Product Solutions Company - December 11, 2025

Source: https://www.globalkeysolutions.net/records/483/exxonmobil-product-solutions-company/6260797e-3f8f-4f4d-b8fc-691b5763e5aa

> FDA 483 for Exxonmobil Product Solutions Company on December 11, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Exxonmobil Product Solutions Company
- Inspection Date: 2025-12-11
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Exxon mobil Product Solutions Company in Baton Rouge, LA, received a Form 483 following an inspection of its API manufacturing facility. The inspection revealed significant deficiencies in the firm's quality unit responsibilities, including inadequate change control, insufficient investigations into stability failures, and improper stability study practices. Additionally, the firm's cGMP training was found to be inadequate for pharmaceutical API manufacturing.

## Related Documents

- [EIR - 2013-03-21](https://www.globalkeysolutions.net/records/eir/exxonmobil-product-solutions-company/53416370-c6bc-4e98-ac79-1b0ea273f2c5)
- [EIR - 2016-04-21](https://www.globalkeysolutions.net/records/eir/exxonmobil-product-solutions-company/88fed02e-9e74-4007-b291-41937d05ce7e)

## Related Officers

- [Rodney L. Tinzie](https://www.globalkeysolutions.net/people/rodney-l-tinzie/6f2bba0d-14c2-4eb5-b6a0-ececb5d7d162)
- [Medical Officer at FDA](https://www.globalkeysolutions.net/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.globalkeysolutions.net/companies/exxonmobil-product-solutions-company/8e83c4a4-cc31-4bfd-abc9-d6f2df29259f

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea