New leadership and spending--as much as $375 million over the next three years--highlight Hospira's ($HSP) plans to get manufacturing operations up to GMP par. MedCity reports that a "hiring blitz" is on for the drugmaker's Rocky Mount, NC, plant, used in the production of parenterals and a part of the company's contract manufacturing business. MedCity said the plant provides 25% of Hospira's annual revenue.
Some 80% of the spending is expected to go to Rocky Mount, the report said. The remediation effort will encompass both the pharma and medical device sides of the house and will take place over three years.
"Quality assurance auditor" and "senior biological quality supervisor" are among the positions the company wants to fill, according to the report. Hospira currently has 153 openings at Rocky Point and hopes to make "20 to 25 priority hires for permanent positions by Dec. 19," the report said.
Operations will continue while remediation is under way, and the company's CEO estimates it is at between 60% to 70% of its normal production capacity, the report said. Hospira has enlisted Quintiles and IHL Consulting Group for support in the effort.
Transferring manufacturing operations to other Hospira sites was ruled out because of the time required to gain FDA approval. Others have used this tactic with success, however. APP Pharmaceuticals ($APPX) recently boosted production of the anesthetic propofol, a longstanding drug in short supply, by working with parent Fresenius Kabi ($APCVZ) and the FDA to begin production at Fresenius' FDA-approved facilities in Europe.
Hospira received an FDA warning letter for the Rocky Mount site in April 2010. Subsequent inspections this past June and August yielded Form 483 inspection reports containing 18 and 3 observations, respectively, regarding production matters still in need of remediation. An Austin, TX, sterile-drug manufacturing facility, inspected in April 2011, earned an 11-count Form 483 indicating a lack of QC-unit responsibility, a failure to reject sub-par products, and insufficient personnel training.
- read the story
- here's the Rocky Mount June 483 report
- here's the August report
- and here's Warning Letter 10-ATL-12