Just when Hospira Inc.'s Rocky Mount, NC–manufacturing facility was starting to think it could breathe a little easier, FDA delivered another Warning Letter.
The Lake Forest, IL-–based manufacturer of pharmaceuticals, other injectables, and infusion pump technologies says it has spent more than $200 million modernizing and improving its North Carolina facility in response to a 2010 Warning Letter. The company has spent more than $1 billion across its global operations. But still FDA says things aren't quite as they should be.
The latest Warning Letter, delivered March 10, was disclosed in a Form 8-K filing Hospira made with the Securities and Exchange Commisssion (SEC) following receipt of the letter. The inspections, which took place last Fall, found several lapses. These were addressed in a December 10 response by the company, and this Warning Letter is FDA's reply to that response.
The violations detailed in the latest Warning Letter follow up on ongoing-issue concerns.
Hospira produced this promotional video in an effort to regain the trust of investors and patients.
FDA wants further documentation of Hospira's justification for releasing a lot of PCA injectors and vials in spite of that lot having failed leak tests. FDA says that at least one Adverse Event Report was filed stemming from units from that lot.
Another area of concern was the firm's lack of controls to monitor the product bioburden of some presterilized devices that are included in the EO sterilization process. Hospira's reply had stated that “the assembly bioburden would not be expected to be high due to the controlled manufacturing process,” so FDA requested that the firm “provide additional information concerning the adequacy of the aseptic area where these products are assembled.”
The third point is also a documentation issue. This one is related to the release of a lot of sterile empty vials from the same parent lot as those that were found to contain particulates. Apparently FDA still wants to know why they did it.
Find out more about the medical device industry—including its technology, supplier networks, and much more—at BIOMEDevice, March 26-27, 2014 in Boston.
FDA's fourth point faults the adequacy of the company's complaints procedures. Specifically, procedures for “receiving, reviewing, and evaluating complaints by a formally designated unit”
And finally, Hospira's corrective and preventive action (CAPA) procedures have not been adequately established. FDA said, “Your firm has several CAPAs with extended due dates and there is no indication that controls are in place to prevent recurrences of the non-conformances while the CAPAs remain open.” The inspector also notes that “several CAPAs were observed to be closed without any effectiveness checks,” but he concludes, “We have reviewed your responses in regard to the above observation, and acknowledge that they appear to be adequate but will require verification during our next inspection.”
