Abbott Labs Faces FDA Warning Letter Over Sterilization and Process Changes

Strategic Insights -

Abbott Labs, a well-established pharmaceutical firm, has once again drawn the attention of FDA investigators with a warning letter issued on July 3. This time, the scrutiny is focused on the company's North Chicago facility, where inspectors found issues with sterilizer filter validation studies and product testing procedures for hemin and panhematin. The warning letter highlights Abbott's failure to disclose changes to pyrogen testing and production processes for Panhematin, as well as inadequate responses to previous concerns raised by FDA. Despite the company's promises to address these issues, FDA remains unsatisfied, demanding more detailed information on the implementation of corrective actions.

Key Takeaways:

  • Abbott Labs' North Chicago facility was inspected from March 13-22, covering the production of hemin and panhematin.
  • The facility failed to complete product-specific sterilizer filter validation studies for bacterial challenge and extractables.
  • The company did not establish and follow procedures for selecting sterility test samples for Panhematin, compromising its representation of all stages of the filling operation.
  • Abbott changed the site of pyrogen testing for Panhematin and altered the temperature range and reflux time in a reactor used to make hemin.
  • The firm's response to FDA's concerns was deemed insufficient, with the agency seeking more detail on the completion of concurrent validation regarding maximum processing times.
  • Abbott has promised to include information regarding the pyrogen test site in the product's annual report, but FDA has instructed the company to file a CBE-30 supplement.

Statistics:

  • FDA inspection of the North Chicago facility took place from March 13-22.
  • Three-page warning letter was issued on July 3, detailing concerns over sterilization and process changes.
  • Abbott's April 6 response to FDA's initial concerns was deemed "inadequate" by the agency.

Sources:

  • Quinn, John (2022, July 3) "Abbott sees FDA close out inspectional findings after warning letter." Modern Healthcare.