Pfizer's Hospira Plant Receives FDA Form 483

A Pfizer manufacturing site for injectable drugs, Hospira Healthcare in Tamil Nadu, India, has received a 32-page Form 483 from the FDA, noting 11 inspection observations.

The citations identified several manufacturing and quality control issues with the plant, including the following:

• Quality control procedures were not adequately followed.Pfizer failed to ensure that all production and laboratory control operations were consistent with current good manufacturing practices.
• The testing and release of final drug products did not include appropriate determination of final specifications for the identity and strength of each active ingredient.According to the FDA, the quality control chemistry analysts manipulated test sample weights to obtain passing test results for several batches of a drug product.
• Pfizer failed to thoroughly review any unexplained discrepancies.The manufacturing site did not complete laboratory and customer complaint investigations thoroughly and within a reasonable time period.
• Procedures designed to prevent contamination of drug products were not established, written, or followed.The FDA noted that there was no documented evidence in the commercial batch records about the end time of the interventions, and not all corrective interventions performed during the aseptic filling process were documented in batch records.

Hospira, which was acquired by Pfizer in 2015, has been the subject of several 483s and FDA warning letters in manufacturing sites outside of India as well, specifically across the Americas, as well as in Italy. Additionally, according to Pfizer, Hospira has issued 11 nationwide recalls in the United States since 2010.

“We’re disappointed with the outcome of a recent regulatory inspection at our manufacturing facility. We have submitted a comprehensive response to the FDA and are committed to implementing the necessary improvements and to ensuring the quality of our medicines,” said Pfizer spokesperson Steve Danehy, in a recent interview. “Pfizer is committed to product quality and we have voluntarily paused production at our Irungattukottal, India site.”

In addition to its other products, Pfizer currently has 6 biosimilars in registration or phase 3 development, including an adalimumab referencing Humira, a bevacizumab referencing Avastin, an epoetin alfa referencing Epogen and Procrit, a filgrastim referencing Neupogen, a rituximab referencing Rituxan/MabThera, and a trastuzumab referencing Herceptin. However, the Hospira plant is not involved in the manufacturing of biosimilars.