FDA 483 - SSG Ventures - September 30, 2021

SSG Ventures, a drug manufacturer in Carle Place, NY, was cited for significant deficiencies across its quality system. The inspection revealed a pervasive lack of written procedures, process validations, finished product testing, and adequate record-keeping, indicating a fundamental failure to adhere to cGMP requirements. These issues suggest a high risk to drug product quality, identity, strength, and purity.