FDA EIR - United Guardian Inc - August 02, 2018

The FDA conducted an inspection of United Guardian Inc., a pharmaceutical manufacturer in Hauppauge, NY, from July 24 to August 2, 2018. This inspection, performed under the Compliance Program Guidance Manual (CPGM) 7356.002 for Drug Manufacturing Inspections, identified nine significant violations of Current Good Manufacturing Practices (CGMP), primarily governed by 21 CFR Part 211. Key issues included the absence of written procedures for critical production and process controls, such as manufacturing process validation for Clorpactin WCS-90 and comprehensive equipment qualification. The company also lacked validated analytical test methods for Clorpactin WCS-90 and a formal procedure for New Drug Application Field Alert Reporting for Renacidin Irrigation Solution.

Further deficiencies involved inadequate storage conditions for drug products due to a lack of temperature control in the finished goods warehouse, and insufficient controls over computerized laboratory systems, including shared access passwords and unreviewed audit trails, raising data integrity concerns. Other observations noted unqualified secondary reference standards, unsigned annual product reviews, and a failure to visually inspect reserve samples annually for deterioration. United Guardian Inc. acknowledged all observations listed on the FDA Form 483 and committed to providing a written response detailing corrective actions within 15 business days.