FDA 483 - South Berwick Pharmacy Seacoast Compounding, Inc. - September 30, 2022

South Berwick Pharmacy Seacoast Compounding, Inc. in South Berwick, ME, was inspected as a producer of non-sterile drugs and received a Form 483 with significant observations. The inspection revealed critical issues including inadequate controls to prevent cross-contamination of hazardous drugs, widespread non-microbial contamination and vermin in the production area, and the use of non-pharmaceutical grade and expired components in drug products. These conditions indicate serious deficiencies in facility control and quality assurance.