Nanjing Maohai Biotech Co. – FDA Warning Letter, Oct 28, 2010

On August 5, 2011, the FDA issued a Warning Letter to Nanjing Maohai Biotech Co. following an October 25-28, 2010 inspection of their drug manufacturing facility in China. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for drug manufacturing, rendering their (b)(4) product adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure of the quality unit to review batch production and laboratory control records:** The firm lacked raw data for (b)(4) testing of (b)(4) lots, relying on summary results via text, email, or phone from a contract laboratory. The contract laboratory also provided only partial HNMR spectra, preventing a full review for impurities. The quality unit is responsible for all data from contract laboratories. 2. **Failure to thoroughly investigate and resolve quality-related complaints:** Four complaints regarding (b)(4) lots failing customer specifications for the (b)(4) test were not properly documented or investigated. Raw data for retesting was unavailable. Another complaint about an unknown impurity in an (b)(4) lot via HNMR was not investigated. 3. **Failure to evaluate suppliers and adequately test incoming materials:** The firm had not evaluated suppliers for (b)(4), (b)(4), and (b)(4