S2 Equipment LLC – FDA 483, Jun 8, 2026

S2 Equipment LLC in Farmington Hills, MI, a manufacturer of sterile injectable drug products, received a Form 483 citing significant deficiencies across its quality system. The inspection revealed inadequate investigations into out-of-specification results, a lack of essential quality control unit procedures, and scientifically unsound visual inspection methods. Additionally, the firm failed to demonstrate proper environmental controls for sterile manufacturing and lacked independent verification in laboratory records, indicating severe issues with product quality assurance.