No warning letters were posted this week due to the partial government shutdown. However, there was one warning letter that posted elsewhere that focused on aseptic processing and data integrity.
- Akorn, Inc. (Decatur, IL) received a warning letter on January 4, 2019 based on the outcome of an inspection at their site ending May 16, 2018. The deficiencies are in the area of aseptic processing and data integrity. FDA advises the firm to employ qualified consultants to help them come into GMP compliance and suggests they employ ICH Q8(R2), Q9 or Q10 to improve their quality system. FDA also asked them to address their ‘short’ version of data integrity remediation. Deficiencies include but are not limited to:
- Poor aseptic behavior including failure to log interventions in the batch records; use of gloves from non-integral packaging where foreign particles were evident; inadequate cleanroom design.
- Personnel monitoring is inadequate because staff sanitized their hands prior to sampling, and failure to trigger an investigation when staff in the ISO 5 cabinet has one CFU/glove on a repeated basis.
- Cleaning program is inadequate because steps were skipped, not performed properly and some equipment was not sanitized.
- The firm did not perform impurity testing during stability on two products since 2016. At the time of the inspection, the firm did not have a validated method.