K.C. Pharmaceuticals, Inc – FDA 483, Feb 13, 2023

An FDA inspection of K.C. Pharmaceuticals, Inc., a manufacturer of sterile drug products, was conducted from January 18 to February 13, 2023. The inspection revealed ten significant observations indicating deficiencies in the company's adherence to Current Good Manufacturing Practices (cGMP).

Key issues included a repeat observation concerning inadequate control procedures and validation of manufacturing processes, specifically flawed smoke studies for sterile filling lines that did not accurately simulate production conditions. The facility also lacked secure equipment for controlling air pressure differentials in controlled environment rooms, enabling unauthorized adjustments to alarm limits. Cleaning procedures for aseptic processing areas, including compounding tanks and filling lines, were found to be unvalidated, posing a risk of residue carryover.

Further observations noted insufficient investigation of product complaints, with retention samples not undergoing full release testing. Laboratory records for complaint investigations lacked required secondary review signatures. Critical problems with the purified water system were identified, including unreplaced components, a non-functional UV sanitization light, unvalidated modifications, and standing water. Additionally, the firm failed to adequately validate sterilization processes, bioburden testing methods, and electronic spreadsheets used for critical release testing calculations. Lastly, the Quality Control unit did not fully follow its own procedures for completing and verifying deviation and out-of-specification reports. K.C. Pharmaceuticals, Inc. is required to address these findings with comprehensive corrective and preventive actions to ensure compliance.