FDA WARNING_LETTER - K. C. Pharmaceuticals Inc. - December 30, 2009

On May 21, 2010, the FDA issued a Warning Letter to K.C. Pharmaceuticals Inc. following a December 14-30, 2009 inspection of their Pomona, CA facility. The inspection revealed significant violations of Quality System Regulations for Medical Devices (21 CFR Part 820) and Current Good Manufacturing Practice (CGMP) Regulations for Finished Pharmaceuticals (21 CFR Parts 210 and 211), rendering their medical devices and drug products adulterated.

Key violations included: 1. **Inadequate Process Validation (21 CFR § 820.75(a))**: Failed aseptic filling process validations in March and May 2009, with contaminated units, yet lots of Sterile Saline Solution were filled and released between these failures without re-qualification. The firm's response was deemed inadequate for not explaining why products were released before re-qualification and lacking evidence of corrective action implementation. 2. **Insufficient Investigations (21 CFR § 211.192)**: Investigations into media fill failures were inadequate, attributing issues solely to improper aseptic techniques without scientific justification. The firm failed to re-validate filling operations or thoroughly investigate microbial contamination in the water system, which was identified as a source of waterborne microorganisms. The FDA questioned the water system's design and qualification. 3. **Deficient Equipment Design (21