FDAnews Drug Daily Bulletin

FDA Hits API Firm With Warning Letter for Data Integrity, Misbranding

March 21, 2017

The FDA has issued a warning letter to an API manufacturer in Hubei, China, citing branding and data integrity issues.

The Lumis Global Pharmaceuticals facility drew a warning following a September 2016 inspection. According to the agency, the facility did not properly transfer quality and regulatory information received from the original API manufacturer to its customers.

Lumis officials failed to take proper actions during repackaging, holding and relabeling operations to prevent loss of API identity and confusion over which materials can and cannot be released. The facility’s documentation for relabeling did not include the time and date of relabeling or the names of the relabeling staff.