FDA EIR - Pharmaceutics International Inc - September 29, 2021

An FDA inspection of Pharmaceutics International Inc. (Pii) in Hunt Valley, MD, was conducted from July 26, 2021, to September 29, 2021. This comprehensive inspection provided current Good Manufacturing Practices (cGMP) surveillance and pre-approval coverage, adhering to regulatory frameworks such as CP 7356.002. The inspection unveiled substantial compliance issues, many of which were repeat observations from a previous inspection in late 2020 that resulted in an Official Action Indicated (OAI) classification.

A 10-item Form FDA 483, detailing inspectional observations, was issued to Pii's President/CEO. Prominent violations included a failure to thoroughly review unexplained manufacturing discrepancies, inadequate written procedures and adherence within the quality control unit, and insufficient controls over computer systems for record changes. The FDA also cited deficient equipment cleaning and maintenance protocols, lack of appropriate equipment cleaning intervals, and inadequate acceptance criteria for quality control testing. Further issues involved the absence of established time limits for production phases, failure to retest approved components after prolonged storage, and unestablished or unfollowed procedures for drug product warehousing. Six of these ten observations were repeat findings, highlighting persistent systemic problems within the company.

Additional concerns noted during the inspection included uninvestigated repeated dissolution failures, data integrity discrepancies concerning sample availability, and production challenges like in-process tablet hardness failures without proper root cause analysis. The firm's quality management system demonstrated limitations in tracking and trending quality events, with many investigations closed as events without sufficient scientific rationale or escalation, even when warranted. Storage deficiencies, such as overloaded chambers and unlabeled products, were also identified. Pharmaceutics International Inc. management acknowledged the observed deficiencies and committed to providing a written response outlining corrective actions within 15 business days.