Kalchem International, Inc. – FDA Warning Letter, Feb 21, 2020

The FDA inspected Kalchem International, Inc. from February 10-21, 2020, identifying significant violations of CGMP for finished pharmaceuticals (21 CFR 210 and 211) and deviations from CGMP for active pharmaceutical ingredients (API). This renders their drugs adulterated under section 501(a)(2)(B) of the FD&C Act.

Key violations include: - **Finished Drug Violation:** The firm shipped an OTC drug product, "(b)(4)," before receiving the certificate of analysis and prior to batch record review and approval, violating 21 CFR 211.165(a). The firm's response was inadequate, lacking a comprehensive CAPA plan. - **API CGMP Deviation:** The Quality Unit failed to ensure API compliance, including inadequate recordkeeping and review for relabeled APIs, and lacking a written procedure for relabeling. An incorrect lot number was shipped for Lidocaine HCL, undetected until the FDA inspection. The firm's response was inadequate, lacking a risk assessment and copies of new/revised procedures. - **API Misbranding Violation:** API labels, such as for Lidocaine HCl, Gabapentin, and Promethazine HCl, falsely imply Kalchem is the sole manufacturer and bear incorrect lot numbers, misbranding them under section 502(a) of the FD&C Act. - **Unapproved New