# FDA 483 - Pharmacia & Upjohn Company LLC - May 11, 2021

Source: https://www.keypedia.com/records/483/pharmacia-upjohn-company-llc/03a5c5e3-403e-4ac5-a78c-0a5ce0c56a58

> FDA 483 for Pharmacia & Upjohn Company LLC on May 11, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmacia & Upjohn Company LLC
- Inspection Date: 2021-05-11
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Pharmacia & Upjohn Company, LLC in Kalamazoo, Michigan, a licensed biological drug manufacturer, identified significant deficiencies in quality systems related to COVID-19 vaccine production and general manufacturing controls. Observations included inadequate operator awareness and SOPs leading to unlabeled vaccine vials, insufficient review of personnel monitoring excursions, and failures in investigation follow-up and CAPA effectiveness checks. Additionally, the firm did not properly review and approve changes to written procedures, including a validated cleaning process, and had an inadequate SOP change management template.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [investigator](https://www.keypedia.com/people/janet-l-bowen/be89d94b-a945-4c6e-8981-fb11f750bbe8)
- [investigator](https://www.keypedia.com/people/brantley-s-collins/c806aac1-3d89-4427-8aeb-6d9db6dfc2f4)

Company: https://www.keypedia.com/companies/pharmacia-upjohn-company-llc/de0a9227-069b-44f4-a9b3-21db78c27480

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0