483
Pharmacia & Upjohn Company LLCPharmacia & Upjohn Company LLC – FDA 483, Sep 21, 2018
Record Details
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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ID · 007df747-38a5-4068-966c-9087c0f4a9d8
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