FDA EIR - Woodstock Sterile Solutions Inc - May 28, 2021

An FDA inspection of Woodstock Sterile Solutions Inc. in Woodstock, IL, took place from May 24-28, 2021. The inspection evaluated the firm's readiness for commercial manufacturing, conformance to application, and data integrity, operating under the Food, Drug and Cosmetic Act and Good Manufacturing Practices (CGMP) framework. Significant violations documented in an FDA-483 included inadequate validation of cleaning methods, with non-specific testing failing to detect residues and lacking proper investigation. Controls over computer systems for production equipment were deficient, lacking unique user logins, audit trails, and data backups, which compromised data integrity. The firm also failed to properly qualify equipment to prevent cross-contamination from various drug products. Other issues included non-concurrent documentation of process controls, insufficient examination and release of drug substances by Quality before use, and incomplete equipment logbooks. A critical finding noted the absence of appropriate laboratory testing for *Burkholderia cepacia complex* in non-sterile products. Verbal observations also pointed to unperformed shipping studies and incomplete quality approval of CGMP documents. Woodstock Sterile Solutions Inc. was requested to submit a response with corrective and preventive actions within 15 business days.