FDA WARNING_LETTER - Cispharma Inc. - April 23, 2012

The FDA issued a Warning Letter to Cispharma, Inc. following a March-April 2012 inspection, identifying significant and repeat violations of current Good Manufacturing Practice (CGMP) regulations (21 CFR Parts 210 and 211). These violations render their drug products adulterated under 21 U.S.C. 351(a)(2)(B). The FDA noted a lack of a robust quality system, with several deficiencies recurring from a January 2011 inspection.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** Failure to thoroughly investigate unexplained discrepancies, such as commingled tablets and an employee accident, with insufficient corrective actions proposed. 2. **Inadequate Production and Process Controls (21 CFR 211.100(a)):** Lack of adequate validation for coating processes for Salsalate, Acetaminophen, and Aspirin tablets, leading to quality issues like surface erosion, chipping, and specks, and reliance on end-product sorting instead of process control. 3. **Unsound Specifications and Test Procedures (21 CFR 211.160(b)):** Failure to validate test procedures and establish proper integration parameters for chromatographic methods. 4. **Inadequate Identity Testing of Components (21 CFR 211.84(d)(2