FDA 483 - K.C. Pharmaceuticals, Inc - January 22, 2020

K.C. Pharmaceuticals, Inc., located in Pomona, CA, underwent an FDA inspection from January 22 to January 30, 2020. The inspection, focusing on their sterile OTC drug manufacturing processes, particularly eye drops, revealed several significant issues.

The primary violations noted were inadequate investigation and documentation of unexplained discrepancies in air monitoring results. Specifically, multiple batches of eye drops were released despite findings of microbial contamination without thorough root cause analysis or implementation of corrective and preventative actions. These discrepancies were documented in several non-conformance reports (NCRs) dating from 2018 to early 2020.

Additionally, the inspection identified deficiencies in equipment and procedures meant to control microbial contamination. The aseptic filling line lacked adequate barriers to prevent human contamination, and equipment used in sterile environments was not stored in hermetically sealed containers, risking sterility.

The FDA's observations highlight a failure to establish robust procedures to prevent microbiological contamination, which is critical under the regulatory framework governing sterile drug manufacturing. K.C. Pharmaceuticals is required to address these issues by implementing comprehensive corrective actions, ensuring thorough investigation of discrepancies, and enhancing controls to maintain product sterility. The company must communicate their corrective action plans to the FDA to demonstrate compliance and prevent potential enforcement actions.