FDA 483 - Birchwood Laboratories LLC - August 19, 2022

Birchwood Laboratories, LLC, an OTC drug manufacturer in Eden Prairie, MN, was cited for significant quality control, equipment cleaning, data integrity, and facility sanitation deficiencies. The inspection revealed failures in following quality unit procedures, lack of cleaning validation for multi-use equipment, inadequate computer system controls allowing data manipulation, and unsanitary conditions in production areas. These issues indicate a moderate level of non-compliance with GMP regulations.