South Berwick Pharmacy Seacoast Compounding, Inc. – FDA 483, Sep 30, 2022

This FDA Form 483 document outlines observations made during an inspection of a facility involved in drug production. The inspection revealed several significant deficiencies related to the manufacturing of hazardous drugs and overall facility control.

A primary concern was the production of hazardous drugs without adequate containment, segregation, cleaning of work surfaces, and cleaning of utensils. This deficiency directly impacts the prevention of cross-contamination, posing a risk to product quality and safety.

Furthermore, the inspection identified non-microbial contamination within the production area, indicating a failure in maintaining a clean and controlled manufacturing environment. The presence of vermin in the production area was also observed, highlighting a severe lapse in pest control and facility sanitation, which can lead to widespread contamination.

Finally, the facility was found to have used a non-pharmaceutical grade component in the formulation of a drug product. This is a critical violation as it compromises the quality, purity, and safety of the final drug product, potentially rendering it adulterated. These observations collectively point to significant issues within the facility's quality system and manufacturing controls, necessitating immediate corrective actions to ensure compliance with regulatory requirements.