FDA WARNING_LETTER - CMI Cosmetic Manufacturers Inc. - October 24, 2012

On April 25, 2013, the FDA issued a Warning Letter to CMI Cosmetic Manufacturers Inc. following an inspection from October 22-24, 2012. The inspection revealed significant violations of current good manufacturing practice (CGMP) regulations (21 CFR Parts 210 and 211), rendering their drug products adulterated. The firm also failed to fulfill drug establishment registration and listing obligations under Sections 510(i)(1), 510(i)(2), and 510(j) of the Act.

Key violations include: 1. **Failure to test components before use (21 CFR 211.84(a)):** The firm used raw materials without identity testing and relied on supplier Certificates of Analysis (CoAs) without adequate vendor qualification. The firm's response was insufficient, lacking details on testing types and a plan for ensuring unverified components are not used. 2. **Inadequate cleaning and maintenance procedures (21 CFR 211.67(b)):** The firm failed to evaluate cleaning procedure effectiveness, lacking data from cleaning validation, verification, or swab recovery studies for multi-use equipment. The firm's commitment to "test the validity" of SOPs was deemed inadequate without a commitment to cleaning validation studies. 3. **Inadequate master production and control records (21 CFR 2