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Pharmaceuticals / Regulatory Affairs

Pfizer Subsidiary Warned for Drug Quality Concerns

March 21, 2019

The FDA issued a warning to Pfizer subsidiary Hospira Healthcare India for contamination risks, out-of-specification batches and other violations observed at its Chennai, Tamil Nadu facility.

During the facility’s March 27 to April 3, 2018 inspection, growth was discovered on environmental monitoring media plates from aseptic processing lines. After reviewing lab records, the investigator found that the firm had recorded “no growth” results for the plates and staff at the facility confirmed the records didn’t accurately reflect the actual microbial growth seen on the plates.

The FDA called the violations “critical data integrity breaches” that raised serious concerns about the validity of all the facility’s quality control laboratory results.

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