- The FDA has sent Hospira a warning letter chastising the company for failure to properly investigate customer complaints.
- Hospira is in the process of being acquired by Pfizer for $15 billion.
- This is not Hospira's only warning letter. It has received letters in response to problems at its plants in Europe, North America, Asia, and Australia.
As the Pfizer acquisition of Hospira, which makes sterile injectables, moves forward, the latter company continues to face FDA warnings because of various manufacturing problems and problems in its plants. In the case of the latest warning, there were 103 customer complaints about product discoloration.
Other problems included potential microbial contamination at a plant and evidence that employees had either been deleting or overwriting test results on computerized testing equipment. There are even problems at new plants. For example, a huge new plant in Visakhapatnam has not been able to open on time because of FDA concerns.
For its part, Hospira has reaffirmed its commitment to taking necessary corrective actions at all affected plants. Perhaps the Pfizer acquisition will help alleviate some of the manufacturing challenges that Hospira is currently facing.