FDA EIR - Sharp Packaging Services, LLC - February 03, 2017

An FDA inspection of Sharp Corporation in Allentown, PA, was conducted from February 1-3, 2017. The inspection served as a pre-approval assessment for an Abbreviated New Drug Application (ANDA) involving an epinephrine auto-injector combination product, alongside a routine Good Manufacturing Practice (GMP) review of the company's drug repackaging operations. The regulatory framework for this inspection included FDA’s Guide to Inspection of Quality Systems (QSIT) and specific compliance programs for pre-approval inspections, drug repackagers, field alert reporting, and medical device manufacturers. Despite reviewing the firm's quality systems, production controls, and numerous Field Alert Reports (FARs) concerning issues like labeling errors, dissolution failures, and product integrity concerns (many not attributed to Sharp's operations), no formal FDA-483 Inspectional Observations were issued. However, a significant discussion point was raised regarding the company's inability to capture and analyze data on auto-injector units rejected during the assembly process. This lack of data prevents thorough tracking and trending of potential manufacturing issues. As a required action from this discussion, management committed to engaging their software vendor to explore solutions for systematically collecting and analyzing this crucial rejection data. An open nonconformance related to smeared lot numbers on a product was also noted, though it was actively under investigation. Overall, the inspection highlighted an area for improvement in data analysis for rejected units, even without formal regulatory observations.