FDA EIR - Ultra Seal Corporation - June 29, 2018

An FDA inspection of Ultra Seal Corporation, a non-sterile drug packager in New Paltz, NY, was conducted from June 25-29, 2018. This routine GMP surveillance, performed under Compliance Program 7356.002B, identified five significant objectionable conditions, resulting in the issuance of a Form FDA 483. The company operates under the Federal Food, Drug, and Cosmetic Act. The primary issues included a lack of a comprehensive written program for assessing drug product stability, with samples for annual stability studies not loaded in 2016 and 2017 for various products, and no product-specific stability protocols. The company also failed to thoroughly review unexplained discrepancies, specifically five microbiology out-of-specification results for its purified water system, without adequately assessing the impact on affected drug products. Further violations involved the absence of written procedures for production and process controls, leading to inadequate packaging validation practices, such as grouping products without formal viscosity comparisons. Additionally, there were no established written procedures for equipment cleaning and maintenance, failing to address worst-case scenarios or maximum dirty/clean hold times in validation studies. Lastly, drug products were not stored under appropriate temperature conditions, as the warehouse’s temperature mapping had not been updated since structural modifications in 2006/2007. Ultra Seal Corporation’s management acknowledged the observations and committed to providing a written response within 15 working days, indicating plans to hire a consultant to address the stability program deficiencies.