Repeat CGMP Violations at K.C. Pharmaceuticals

An FDA 1/20-2/13 inspection at the K.C. Pharmaceuticals drug manufacturing facility in Pomona, CA, found repeat significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/12 Warning Letter says the specific violations were:

• failure to establish and follow appropriate written procedures to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes;
• failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
• failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products;
• failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that  components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
• failure to establish adequate written responsibilities and procedures applicable to the quality control unit and failure to follow written procedures applicable to the quality control unit.

FDA says the firm’s inspection history indicates that its quality unit is not able to fully exercise its authority and/or responsibilities. The agency acknowledged K.C. suspended production of several redacted over-the-counter drugs and issued a 2/18 drug recall due to failing media fills and a lack of sterility assurance.

The letter says FDA found similar severe CGMP violations in a 2023 inspection and recommends the company retain a qualified consultant to evaluate its operations, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions. The agency recommends that K.C. arrange for a teleconference with FDAS officials to discuss its planned corrective and preventive actions in detail.

K.C. was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.