FDA 483 - Savings Distributors LLC - August 27, 2020

Savings Distributors LLC, a drug repacker in Islandia, NY, was inspected by the FDA from August 24-27, 2020. The inspection revealed significant deficiencies across multiple areas, including failures in quality control unit procedures, lack of written production controls, and inadequate employee training. Further issues included the absence of stability testing, incomplete batch records, insufficient storage areas, improper temperature control for drug products, and failures in sampling and examining packaging materials and retaining reserve samples, indicating a broad lack of adherence to cGMP requirements.