In late August, Shanghai Institute of Pharmaceutical Industry (SIPI) surprised many worldwide by announcing that they received a warning letter from the US Food and Drug Administration and shared their response. The FDA stated that SIPI is listed as a contract testing laboratory that provides active pharmaceutical ingredient characterization and/or identification testing to support multiple abbreviated new drug applications and “planned surveillance and pre-approval inspection” had been required and refused. SIPI’s letter back said inspection wasn’t appropriate as they had no formal contract that would result in an ANDA filing with the FDA. Pink Sheet shares the exact working of the FDA letter, the laboratory’s response, and analysis of the real reason behind the refusal.