FDA WARNING_LETTER - CBSCHEM LIMITED - June 07, 2013

The FDA issued a Warning Letter to CBSCHEM Limited following inspections in April and June 2013 of their pharmaceutical labeler/relabeler facilities in Hong Kong and Tempe, AZ. Investigators identified significant deviations from current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering the APIs adulterated under Section 501(a)(2)(B) and misbranded under Sections 502(a) and 502(i)(1) of the Federal Food, Drug, and Cosmetic Act.

Violations at the Hong Kong facility included failure to maintain complete API records for traceability, inconsistent record retention, and insufficient inventory information. The firm also failed to transfer complete quality and regulatory information to customers, with COAs lacking essential details like the original manufacturer and testing facility. Additionally, there was a failure to control repackaging, relabeling, and holding operations, leading to potential mix-ups due to inadequately labeled storage and unsegregated returned APIs. A significant deficiency was the absence of a Quality Unit responsible for reviewing and approving CGMP documents and assuring product quality.

At the Tempe, AZ facility, the firm failed to relabel and hold APIs under appropriate CGMP controls, evidenced by a mislabeling incident where an excipient container held multiple different APIs, posing a severe consumer hazard. They also failed to maintain complete API records, lacking a quality system to ensure API identity and critical manufacturer information on COAs.

FDA questioned the effectiveness of CBSCHEM's quality system and recommended engaging a third-party CGMP consultant. The firm must provide detailed corrective actions within fifteen working days, including written procedures for record control, information transfer, operational controls, and establishing a Quality Unit. Failure to correct deviations may result in FDA withholding approval of new applications and refusing admission of articles into the U.S.