# FDA 483 - Pharmacia & Upjohn Company LLC - September 21, 2018

Source: https://www.keypedia.com/records/483/pharmacia-upjohn-company-llc/007df747-38a5-4068-966c-9087c0f4a9d8

> FDA 483 for Pharmacia & Upjohn Company LLC on September 21, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pharmacia & Upjohn Company LLC
- Inspection Date: 2018-09-21
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Pharmacia & Upjohn Company, LLC in Kalamazoo, MI, revealed significant deficiencies in manufacturing practices. The firm failed to follow procedures designed to prevent microbiological contamination of sterile drug products, leading to the release of potentially compromised lots. Additionally, employees lacked adequate training for specific operations, and deviations from production and process control procedures were not properly recorded or approved by quality.

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## Related Officers

- [Deputy Commissioner for Foods](https://www.keypedia.com/people/james-k-ireland/78658286-3e62-4069-a8e1-b157aa77c7fe)
- [Scott A. Golladay](https://www.keypedia.com/people/scott-a-golladay/78c90066-7212-4442-900c-5cdcb677aeec)
- [Investigator](https://www.keypedia.com/people/sarah-e-rhoades/d965990c-15cc-4722-b2d0-aea7206c71b0)
- [Emily J. Orban](https://www.keypedia.com/people/emily-j-orban/e0008df4-4986-413d-a943-9fafcf385021)

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