Damaged Equipment Lands Pfizer Subsidiary a 483
King Pharmaceuticals received a Form 483 after agency investigators discovered problems with damaged equipment and cleanroom suits filled with holes.
The agency discovered the quality violations during an August inspection of the Pfizer subsidiary’s Rochester, Mich., facility.
The facility’s micronizer, used to turn the active pharmaceutical ingredient (API) into tiny particles to be put in drug products, was damaged with metal on metal wear. No documents were provided to show that the metal on metal wear is not occurring “during set up of the micronizer, creating the potential for metal particulates to contaminate the active ingredient,” said the FDA.
Investigators also found holes and tears in half suits used by personnel during the micronizing process. One suit had 30 holes and cuts in the outer suit and a tear in the inner suit. While the suit was repaired, there was no proof King performed a leak test to ensure the repairs were adequate, said the five-observation form.
Pfizer said the site is adopting additional processes and procedures to address the agency’s concerns.
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