FDA EIR - Allergan Sales LLC - June 24, 2021

An FDA for-cause GMP inspection was conducted at Allergan Sales LLC, Cincinnati, OH, from May 25 to June 24, 2021. The inspection targeted a prescription drug manufacturer and packager, specifically focusing on continued operations related to their unapproved drug, Armour® Thyroid. This inspection revealed significant issues, many of which were repeat observations from previous inspections. The firm was issued an 8-item FDA Form 483. Key violations included a failure to retain complete metadata for the Armour® Thyroid assay and content uniformity method validation, leading to the use of an unvalidated analytical method for approximately 450 released batches. The validation itself was found inadequate, lacking established accuracy, sensitivity, specificity, and reproducibility for test methods. The firm also failed to use a stability-indicating method for Armour® stability samples and neglected to follow its written stability testing program. Furthermore, Allergan failed to establish scientifically sound and appropriate specifications (a repeat observation from 2019) and to conduct adequate investigations (repeat from 2012 and 2019). Issues also encompassed inadequate follow-up on complaints and failure to update quality agreements as per written procedures (repeat from 2019). Despite verbally discussing the unapproved status of Armour® Thyroid in 2019, Allergan continued its manufacturing and distribution without submitting a Biologics License Application (BLA) since filing an Investigational New Drug (IND) application in 2011. The inspection underscored a persistent lack of compliance with Good Manufacturing Practices (GMP) under the CDER regulatory framework. Management committed to responding to the observations within 15 business days.